STEM-PD Open Label Extension (OLE)

Sponsor

Scion NeuroStim (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04799418

Collaborator

(none)

220

Enrollment

Locations

Arm

Anticipated Duration (Months)

31.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to establish the safety and efficacy of extended twice daily treatments for treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial are eligible for the OLE.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Parkinson's Disease and Parkinsonism	Device: Open Label Extension Study	N/A

Detailed Description

Up to 220 participants will enter an open label extension (OLE) study during which all study participants will receive treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments will be re-introduced for the final 8 weeks (56 days).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Treatment 1 Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.	Device: Open Label Extension Study This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.

Arm

Intervention/Treatment

Experimental: Experimental Treatment 1

Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.

Device: Open Label Extension Study

This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.

Outcome Measures

Primary Outcome Measures

Change from baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score [8 months]
The MDS- NMS is 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. Scores range between 0-832, with the higher score indicating greater non-motor symptom burden. (day 197 score)

Secondary Outcome Measures

Change from baseline in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [8 months]
The MDS- UPDRS Part II is a 13- item patient-reported assessment of activities of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living. (day 197 score)
Change from baseline in the Clinical Global Impression - Improvement (CGI-I) [8 months]
The CGI-I is a clinician assessment the extent of clinically meaningful change that has occurred in the patient's illness at day 113 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson's disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered.
Change from baseline in the MDS-UPDRS Part III [8 months]
The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained blinded rater. Scores range between 0-132 with higher scores indicating more sever motor symptoms. (day 197 score)
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI) [8 months]
The PDQ-39 SI is a 39-item patient-reported quality of life measure that assesses how often people living with PD are affected across 8 dimensions of daily living. Scores range from 0-100, with the higher scores indicating worse perception of quality of life. (day 197 score)

Other Outcome Measures

Change from baseline in the Mini-Balance Evaluation Systems Test [8 months]
a measure of dynamic balance, functional mobility, and gait. This measure will be evaluated as a safety outcome to assess whether device therapy negatively impacts balance or gait for participants with Parkinson's disease (day 197 score)
Change from baseline in the Montreal Cognitive Assessment [8 months]
a screening instrument used to facilitate the assessment of cognitive impairment.
Change from baseline in the Oral Symbol Digit Modality Test [8 months]
a brief and commonly used tests to evaluate processing speed
Change from baseline in the Parkinson's Disease Sleep Scale [8 months]
an assessment to quantify nocturnal sleep issues in Parkinson's disease
Change from baseline in Epworth Sleepiness Scale [8 months]
a brief measure that is commonly used to assess daytime sleepiness
Change from baseline in the Parkinson Anxiety Scale [8 months]
a brief questionnaire to detect anxiety severity in Parkinson's disease
Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue Scale [8 months]
a measure of an individual's level of fatigue during their usual daily activities over the past week
Change from baseline in the Geriatric Depression Scale-15 [8 months]
a short questionnaire for assessing depression in older adults
Change from baseline in the MDS-NMS Non-Motor Fluctuations [8 months]
a rater completed assessment evaluating fluctuations of non-motor symptoms in Parkinson's disease
Change from baseline in the Unified Parkinson's Disease Rating Scale Part IV [8 months]
an assessment of complications of anti-Parkinsonian therapies
Change from baseline in a Non-Motor Symptom focused Clinical Global Impression-Improvement [8 months]
clinician assessment the extent of clinically meaningful change that has occurred as it relates to the patient's non-motor symptoms
Change from baseline in the Zarit Burden Interview [8 months]
measure of caregiving burden completed by caregivers
Change from baseline in the Patient Reported Outcome - Parkinson's Disease [8 months]
a self-rating tool to assess symptom severity in Parkinson's disease
Change from baseline in The Modified Schwab and England Activities of Daily Living Scale [8 months]
a clinical outcome assessment of an individual's ability to function independently in activities of daily living
Change from baseline in EncephaLogTM 3 meter Timed Up and Go Test [8 months]
smart phone application assessment that provides indication of risk of falls in adults
Change from baseline in EncephaLogTM finger tapping test [8 months]
smart phone application providing a quantitative measure of bradykinesia
Change from baseline in EncephaLogTM 10m Timed Up and Go (10m TUG) [8 months]
smart phone application that measures gait and that provides indication of risk of falls in adults
Change from baseline in Unified Parkinson's disease Rating Scale Part I (UPDRS I) [8 months]
a measure of mentation, behavior, and mood in Parkinson's disease
Change from baseline in Hoehn & Yahr (H&Y) [8 months]
staging tool describing the level of disability in Parkinson's disease
Change from baseline in Patient Global Impression of Improvement [8 months]
a patient determined scale to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Completion of the study activities in the STEM-PD RCT trial. l.
Participants must be willing and able to give consent to participate in the study trial.

Exclusion Criteria:

Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial.
Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Headlands Research Orlando	Orlando	Florida	United States	32819
2	University of Kansas Medical Center - Parkinson's Disease Center	Kansas City	Kansas	United States	66160
3	Quest Research	Farmington Hills	Michigan	United States	48334
4	University of New Mexico	Albuquerque	New Mexico	United States	87131
5	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina	United States	27607
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	Riverside Neurology Specialists	Newport News	Virginia	United States	23601