TARGET-PD: Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
Sponsor
Global Kinetics Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT03984305
Collaborator
(none)
41
17
2
12.1
2.4
0.2
Study Details
Study Description
Brief Summary
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).
Study Design
Study Type:
Interventional
Actual Enrollment
:
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
Masking:
Single (Participant)
Masking Description:
Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG results to be incorporated into their standard of care practice.
Primary Purpose:
Supportive Care
Official Title:
Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
Actual Study Start Date
:
Oct 15, 2019
Actual Primary Completion Date
:
Oct 16, 2020
Actual Study Completion Date
:
Oct 16, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PKG+ Group For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. |
Device: Personal KinetiGraph® (PKG®) Watch
The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
An application to configure the data logger and transfer the acquired data at the end of a recording.
Device: Personal KinetiGraph® (PKG®) Report
The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.
The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.
|
| Placebo Comparator: PKG- Group For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. |
Device: Personal KinetiGraph® (PKG®) Watch
The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
An application to configure the data logger and transfer the acquired data at the end of a recording.
|
Outcome Measures
Primary Outcome Measures
- Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Secondary Outcome Measures
- Percentage of Responders for Total MDS-UPDRS [4 month Follow-up Visit]
Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of 4.3 (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.)
- Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in the patient reported quality of life questionnaire PDQ-39 from Baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
- Change in MDS-UPDRS Total From Baseline [From Baseline to the 1, 2 and 3-Year Annual Visits]
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
- Change in MDS-UPDRS Sub Part I [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
- Change in PKG Bradykinesia Score (BKS) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia.
- Change in PKG Dyskinesia Score (DKS) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia.
- Change in PKG Fluctuation Score (FDS) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation.
- Change in PKG Percent Time Tremor (PTT) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in the PKG reported percent time in tremor from baseline, max 100%
- Change in Levodopa Equivalent Dose (LED) [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in LED from baseline to 4-months
- PKG Patient Survey [Outcome measure evaluated at the 4-month Follow-up Visit]
Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson's disease. Questions in the survey are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared.
- Change in MDS-UPDRS Sub Part II [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
- Change in MDS-UPDRS Sub Part III [From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)]
Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson's disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
- Change in MDS-UPDRS Sub Part IV [From Baseline to the 4-month Follow-up Visit]
Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Eligibility Criteria
Criteria
Ages Eligible for Study:
46 Years
to 83 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Able and willing to sign a written informed consent for study participation
-
Presumed to have Levodopa responsive idiopathic Parkinson's Disease
-
Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
-
Has not been previously managed with the PKG
Exclusion Criteria:
-
Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
-
MoCA score <23 at screening visit
-
Diagnosis of Essential Tremor
-
Wheelchair bound or bedridden
-
Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
-
In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington Regional Medical Center | Fayetteville | Arkansas | United States | 72703 |
| 2 | University of Arkansas Medical Center | Little Rock | Arkansas | United States | 72205 |
| 3 | Parkinson's Disease and Movement Disorders Center of Silicon Valley | Menlo Park | California | United States | 94025 |
| 4 | Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | United States | 33486 |
| 5 | University of Florida | Gainesville | Florida | United States | 32608 |
| 6 | University of South Florida | Tampa | Florida | United States | 33612 |
| 7 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 8 | Kaiser Mid-Atlantic Permanente Center | Rockville | Maryland | United States | 20852 |
| 9 | Neurology Center of New England | Foxboro | Massachusetts | United States | 02035 |
| 10 | Michigan State University | East Lansing | Michigan | United States | 48824 |
| 11 | University of Nebraska | Omaha | Nebraska | United States | 68198 |
| 12 | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | United States | 89106 |
| 13 | Parkinson's Disease and Movement Disorders Center of Long Island | Commack | New York | United States | 11725 |
| 14 | Weill Cornell | New York | New York | United States | 10021 |
| 15 | University of Texas | Houston | Texas | United States | 77030 |
| 16 | Marshall University | Huntington | West Virginia | United States | 25701 |
| 17 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Global Kinetics Corporation
Investigators
- Principal Investigator: Raja Mehanna, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.
- Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
Responsible Party:
Global Kinetics Corporation
ClinicalTrials.gov Identifier:
NCT03984305
Other Study ID Numbers:
- Study 003
First Posted:
Jun 13, 2019
Last Update Posted:
Feb 8, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Global Kinetics Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Period Title: Overall Study | ||
| STARTED | 23 | 18 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 23 | 18 |
Baseline Characteristics
| Arm/Group Title | PKG+ Group | PKG- Group | Total |
|---|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. | Total of all reporting groups |
| Overall Participants | 23 | 18 | 41 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
74.6
(4.4)
|
71.4
(5.8)
|
73.2
(5.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
30.4%
|
10
55.6%
|
17
41.5%
|
| Male |
16
69.6%
|
8
44.4%
|
24
58.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
21
91.3%
|
15
83.3%
|
36
87.8%
|
| Unknown or Not Reported |
2
8.7%
|
3
16.7%
|
5
12.2%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
21
91.3%
|
16
88.9%
|
37
90.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
8.7%
|
2
11.1%
|
4
9.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
23
100%
|
18
100%
|
41
100%
|
| Years since Parkinson's Disease Diagnosis (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
5.4
(4.7)
|
6.3
(4.4)
|
6.3
(4.5)
|
Outcome Measures
| Title | Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
|---|---|
| Description | The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. Subjects were excluded from the analysis if they did not complete the 4 month Follow-up Visit or did not complete all parts of the MDS-UPDRS assessment at the Baseline and/or 4 month Follow-up Visit. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 16 | 11 |
| Mean (Standard Deviation) [score on a scale] |
0.9
(19.9)
|
0.8
(12.0)
|
| Title | Percentage of Responders for Total MDS-UPDRS |
|---|---|
| Description | Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of 4.3 (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.) |
| Time Frame | 4 month Follow-up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 16 | 11 |
| Count of Participants [Participants] |
6
26.1%
|
3
16.7%
|
| Title | Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) |
|---|---|
| Description | Change in the patient reported quality of life questionnaire PDQ-39 from Baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 15 |
| Mean (Standard Deviation) [score on a scale] |
6.3
(17.5)
|
-1.5
(5.1)
|
| Title | Change in MDS-UPDRS Total From Baseline |
|---|---|
| Description | The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 1, 2 and 3-Year Annual Visits |
Outcome Measure Data
| Analysis Population Description |
|---|
| This Secondary Outcome Measure was not evaluated because the study was discontinued after completion of the 4-month Follow-up Visit. Subjects did not complete the 1, 2, or 3-Year Annual Follow-up Visits. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 0 | 0 |
| Title | Change in MDS-UPDRS Sub Part I |
|---|---|
| Description | Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 18 | 15 |
| Mean (Standard Deviation) [score on a scale] |
-0.3
(4.7)
|
1.1
(3.1)
|
| Title | Change in PKG Bradykinesia Score (BKS) |
|---|---|
| Description | Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia. |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 14 |
| Mean (Standard Deviation) [score on a scale] |
-1.4
(1.9)
|
-1.2
(2.5)
|
| Title | Change in PKG Dyskinesia Score (DKS) |
|---|---|
| Description | Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia. |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 14 |
| Mean (Standard Deviation) [score on a scale] |
0.1
(0.7)
|
0.2
(1.3)
|
| Title | Change in PKG Fluctuation Score (FDS) |
|---|---|
| Description | Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation. |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 14 |
| Mean (Standard Deviation) [score on a scale] |
-0.2
(1.3)
|
-0.5
(1.6)
|
| Title | Change in PKG Percent Time Tremor (PTT) |
|---|---|
| Description | Change in the PKG reported percent time in tremor from baseline, max 100% |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 14 |
| Mean (Standard Deviation) [percentage of time with tremor] |
-1.6
(6.5)
|
-1.6
(5.9)
|
| Title | Change in Levodopa Equivalent Dose (LED) |
|---|---|
| Description | Change in LED from baseline to 4-months |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 15 |
| Mean (Standard Deviation) [levodopa equivalent dose] |
105.2
(229.5)
|
61.7
(164.4)
|
| Title | PKG Patient Survey |
|---|---|
| Description | Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson's disease. Questions in the survey are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared. |
| Time Frame | Outcome measure evaluated at the 4-month Follow-up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 19 | 15 |
| Count of Participants [Participants] |
13
56.5%
|
10
55.6%
|
| Title | Change in MDS-UPDRS Sub Part II |
|---|---|
| Description | Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 18 | 15 |
| Mean (Standard Deviation) [score on a scale] |
1.5
(7.2)
|
-1.3
(3.5)
|
| Title | Change in MDS-UPDRS Sub Part III |
|---|---|
| Description | Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson's disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 16 | 11 |
| Mean (Standard Deviation) [score on a scale] |
-1.6
(9.9)
|
-0.8
(8.3)
|
| Title | Change in MDS-UPDRS Sub Part IV |
|---|---|
| Description | Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). |
| Time Frame | From Baseline to the 4-month Follow-up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. |
| Arm/Group Title | PKG+ Group | PKG- Group |
|---|---|---|
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. |
| Measure Participants | 18 | 15 |
| Mean (Standard Deviation) [score on a scale] |
0.1
(3.5)
|
0.1
(2.0)
|
Adverse Events
| Time Frame | Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits. | |||
| Arm/Group Title | PKG+ Group | PKG- Group | ||
| Arm/Group Description | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. | ||
All Cause Mortality |
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| PKG+ Group | PKG- Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/18 (0%) | ||
Serious Adverse Events |
||||
| PKG+ Group | PKG- Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/23 (13%) | 1/18 (5.6%) | ||
| Infections and infestations | ||||
| Inpatient Hospitalization | 1/23 (4.3%) | 1 | 0/18 (0%) | 0 |
| Renal and urinary disorders | ||||
| Inpatient Hospitalization | 2/23 (8.7%) | 2 | 1/18 (5.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| PKG+ Group | PKG- Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/23 (52.2%) | 3/18 (16.7%) | ||
| Gastrointestinal disorders | ||||
| Unanticipated Clinic Visit | 1/23 (4.3%) | 1 | 0/18 (0%) | 0 |
| General disorders | ||||
| Emergency Room Visit | 1/23 (4.3%) | 1 | 0/18 (0%) | 0 |
| Infections and infestations | ||||
| Urgent Care Visit | 2/23 (8.7%) | 2 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 6/23 (26.1%) | 8 | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||||
| Bothersome Hallucinations | 1/23 (4.3%) | 1 | 0/18 (0%) | 0 |
| Vascular disorders | ||||
| Orthostatic Hypotension | 4/23 (17.4%) | 6 | 2/18 (11.1%) | 2 |
Limitations/Caveats
Early termination leading to small numbers of subjects analyzed
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A participating institution/PI may publish its individual site results; however, the sponsor has the exclusive right to publish the complete accumulated results of the multi-center trial. If a manuscript for the multi-center publication has not been submitted within 12 months of the conclusion or termination of the trial, then the institution/PI may publish a subset of the trial results. The sponsor shall be acknowledged in accordance with scientific practice.
Results Point of Contact
| Name/Title | Director of Clinical Affairs |
|---|---|
| Organization | Global Kinetics Corporation |
| Phone | 612.240.2437 |
| karen.krygier@globalkineticscorp.com |
Responsible Party:
Global Kinetics Corporation
ClinicalTrials.gov Identifier:
NCT03984305
Other Study ID Numbers:
- Study 003
First Posted:
Jun 13, 2019
Last Update Posted:
Feb 8, 2022
Last Verified:
Aug 1, 2021