BOLD: BurstDR™ micrOdosing stimuLation in De-novo Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.
In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Microdosing group Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. |
Device: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
|
Outcome Measures
Primary Outcome Measures
- Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation [baseline and 1 week after trial lead implant (trial stimulation)]
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
- Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 [Baseline and 1 month follow up visit]
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
- Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 [Baseline and 3 month follow up visit]
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
- Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 [Baseline and 6 month follow up visit]
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Secondary Outcome Measures
- Change in Quality of Life Between Baseline and Trial Stimulation [Baseline and 1 week after trial lead implant (trial stimulation)]
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
- Change in Quality of Life Between Baseline and Follow up 1 [Baseline and 1 month follow up visit]
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
- Change in Quality of Life Between Baseline and Follow up 2 [Baseline and 3 month follow up visit]
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
- Change in Quality of Life Between Baseline and Follow up 3 [Baseline and 6 month follow up visit]
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
- Change in Disability Index Between Baseline and Trial Stimulation [Baseline and 1 week after trial lead implant (trial stimulation)]
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
- Change in Disability Index Between Baseline and and Follow up 1 [Baseline and 1 month follow up visit]
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
- Change in Disability Index Between Baseline and and Follow up 2 [Baseline and 3 month follow up visit]
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
- Change in Disability Index Between Baseline and and Follow up 3 [Baseline and 6 month follow up visit]
questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
- Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation [Baseline and 1 week after trial lead implant (trial stimulation)]
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 [Baseline and 1 month follow up visit]
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 [Baseline and 3 month follow up visit]
Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 [Baseline and 6 month follow up visit]
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Other Outcome Measures
- Stimulation ON/OFF Ratio [6 month follow up visit]
Percentage of patients using each ON/OFF ratio
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is able to provide informed consent to participate in the study;
-
Subject diagnosed with chronic intractable pain associated with back and/or limbs;
-
Subject is 18 years of age or older;
-
Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
-
Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;
-
Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
-
Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;
-
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
-
Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study
Exclusion Criteria:
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
-
Subject is currently participating in a clinical investigation that includes an active treatment arm;
-
Subject has been implanted with or participated in a trial period for a neurostimulation system;
-
Subject has an infusion pump;
-
Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
-
Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
-
Subject is immunocompromised;
-
Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
-
Subject has history of cancer requiring active treatment in the last 12 months;
-
Subject has an existing medical condition that is likely to require the use of diathermy in the future;
-
Subject has documented history of allergic response to titanium or silicone;
-
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
-
Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
-
Subject has life expectancy of less than 6 months;
-
Subject is involved in an injury claim under current litigation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thrive Clinic | Santa Rosa | California | United States | 95403 |
| 2 | Nevada advanced pain specialists | Reno | Nevada | United States | 89511 |
| 3 | OnSite Clinical Solutions | Asheville | North Carolina | United States | 28803 |
| 4 | Ambulatory Surgery Center of Killeen | Killeen | Texas | United States | 76542 |
| 5 | Premier Pain Solutions | Charleston | West Virginia | United States | 25301 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Timothy R Deer, MD, The Center for Pain Relief
Study Documents (Full-Text)
More Information
Publications
None provided.- SJM-CIP-10215
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Period Title: Overall Study | |
| STARTED | 60 |
| Spinal Cord Stimulation Trial | 50 |
| Permanent Implant | 35 |
| 1 Month Follow up | 30 |
| 3 Month Follow up | 27 |
| 6 Month Follow up | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 36 |
Baseline Characteristics
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Overall Participants | 49 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
56.8
(3.95)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
30
61.2%
|
| Male |
19
38.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
49
100%
|
| duration of pain (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
9.98
(3.31)
|
Outcome Measures
| Title | Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation |
|---|---|
| Description | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Time Frame | baseline and 1 week after trial lead implant (trial stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 47 |
| Mean (Standard Deviation) [units on a scale] |
-46.28
(23.83)
|
| Title | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 |
|---|---|
| Description | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Time Frame | Baseline and 1 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in VAS score between baseline and 1 month follow up missing data for 2 subjects |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 28 |
| Mean (Standard Deviation) [units on a scale] |
-41.07
(24.74)
|
| Title | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 |
|---|---|
| Description | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Time Frame | Baseline and 3 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in VAS between baseline and 3 month follow up missing data for 2 subject |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 25 |
| Mean (Standard Deviation) [units on a scale] |
-36.56
(29.53)
|
| Title | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 |
|---|---|
| Description | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Time Frame | Baseline and 6 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in VAS score between baseline and 6 months visit |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 24 |
| Mean (Standard Deviation) [units on a scale] |
-36.62
(29.54)
|
| Title | Change in Quality of Life Between Baseline and Trial Stimulation |
|---|---|
| Description | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) |
| Time Frame | Baseline and 1 week after trial lead implant (trial stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in EQ-5D score between baseline and SCS trial 1 subject had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 49 |
| Mean (Standard Deviation) [score on a scale] |
0.172
(0.1625)
|
| Title | Change in Quality of Life Between Baseline and Follow up 1 |
|---|---|
| Description | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) |
| Time Frame | Baseline and 1 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 28 |
| Mean (Standard Deviation) [score on a scale] |
0.148
(0.121)
|
| Title | Change in Quality of Life Between Baseline and Follow up 2 |
|---|---|
| Description | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) |
| Time Frame | Baseline and 3 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 26 |
| Mean (Standard Error) [score on a scale] |
0.106
(0.209)
|
| Title | Change in Quality of Life Between Baseline and Follow up 3 |
|---|---|
| Description | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) |
| Time Frame | Baseline and 6 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in EQ-5D score between baseline and 6 month follow up |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 24 |
| Mean (Standard Deviation) [score on a scale] |
0.148
(0.136)
|
| Title | Change in Disability Index Between Baseline and Trial Stimulation |
|---|---|
| Description | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Time Frame | Baseline and 1 week after trial lead implant (trial stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in ODI score between baseline and SCS trial 3 subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 47 |
| Mean (Standard Deviation) [score on a scale] |
-17.6
(18.15)
|
| Title | Change in Disability Index Between Baseline and and Follow up 1 |
|---|---|
| Description | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Time Frame | Baseline and 1 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in ODI score between baseline and 1 month follow up 2 subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 28 |
| Mean (Standard Deviation) [score on a scale] |
-12.76
(14.5)
|
| Title | Change in Disability Index Between Baseline and and Follow up 2 |
|---|---|
| Description | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Time Frame | Baseline and 3 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in disability score between baseline and 3 month follow up Two subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [score on a scale] |
-17
(19.1)
|
| Title | Change in Disability Index Between Baseline and and Follow up 3 |
|---|---|
| Description | questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Time Frame | Baseline and 6 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in disability score between baseline and 6 month follow up |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 24 |
| Mean (Standard Deviation) [score on a scale] |
-15.5
(16.6)
|
| Title | Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation |
|---|---|
| Description | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) |
| Time Frame | Baseline and 1 week after trial lead implant (trial stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in PCS between baseline and SCS trial One subject had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 49 |
| Mean (Standard Deviation) [score on a scale] |
-8.98
(12.3)
|
| Title | Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 |
|---|---|
| Description | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) |
| Time Frame | Baseline and 1 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in PCS score between baseline and 1 month follow up 2 subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 28 |
| Mean (Standard Deviation) [score on a scale] |
-12.17
(12.83)
|
| Title | Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 |
|---|---|
| Description | Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) |
| Time Frame | Baseline and 3 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in PCS between baseline and 3 month follow up 2 subjects had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [score on a scale] |
-13.32
(14.38)
|
| Title | Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 |
|---|---|
| Description | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) |
| Time Frame | Baseline and 6 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in PCS score between baseline and 6 month follow up 1 subject had missing data |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 23 |
| Mean (Standard Deviation) [score on a scale] |
-13.42
(12.68)
|
| Title | Stimulation ON/OFF Ratio |
|---|---|
| Description | Percentage of patients using each ON/OFF ratio |
| Time Frame | 6 month follow up visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Microdosing Group |
|---|---|
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure Participants | 24 |
| subjects using 360 seconds OFF intervals |
11
22.4%
|
| subjects using 240 seconds OFF intervals |
3
6.1%
|
| subjects using 150 seconds OFF intervals |
3
6.1%
|
| subjects using 120 seconds OFF intervals |
3
6.1%
|
| subjects using 90 seconds OFF intervals |
4
8.2%
|
Adverse Events
| Time Frame | From enrollment to completion of the study at 6 month follow up. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Microdosing Group | |
| Arm/Group Description | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. | |
All Cause Mortality |
||
| Microdosing Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | |
Serious Adverse Events |
||
| Microdosing Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/60 (3.3%) | |
| General disorders | ||
| Hospitalization for abdominal pain | 1/60 (1.7%) | 1 |
| Injury, poisoning and procedural complications | ||
| Subject fractured <1 vertebrae (compression) and was hospitalized overnight | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Microdosing Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/60 (5%) | |
| Injury, poisoning and procedural complications | ||
| Trial lead migration | 3/60 (5%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Filippo Agnesi |
|---|---|
| Organization | Abbott |
| Phone | +19725264860 |
| filippo.agnesi@abbott.com |
- SJM-CIP-10215