Trial Outcomes & Findings for An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects (NCT NCT00567541)
NCT ID: NCT00567541
Last Updated: 2016-04-01
Results Overview
Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From baseline to 48 week follow up
Results posted on
2016-04-01
Participant Flow
Participant milestones
| Measure |
Active BBPM Stimulation
The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment.
|
Sham BBPM Stimulation
The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
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|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active BBPM Stimulation
The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment.
|
Sham BBPM Stimulation
The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.
Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
Baseline characteristics by cohort
| Measure |
Active BBPM Stimulation
n=7 Participants
Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
|
Sham BBPM Stimulation
n=9 Participants
Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
|
Total
n=16 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
35-55 years old
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
56-80 years old
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-white
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 48 week follow upPopulation: Intent to Treat population was analyzed
Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
Outcome measures
| Measure |
Active BBPM Stimulation
n=7 Participants
The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
|
Sham BBPM Stimulation
n=9 Participants
The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
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|---|---|---|
|
Relief of Chronic Shoulder Pain
|
0 participants
|
0 participants
|
Adverse Events
Active BBPM Stimulation
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham BBPM Stimulation
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active BBPM Stimulation
n=7 participants at risk
The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
|
Sham BBPM Stimulation
n=9 participants at risk
The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
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|---|---|---|
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Nervous system disorders
Ischemic Stroke
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
44.4%
4/9 • Number of events 4 • Throughout trial up to one year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/7 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
Musculoskeletal and connective tissue disorders
bone fracture
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
Other adverse events
| Measure |
Active BBPM Stimulation
n=7 participants at risk
The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
|
Sham BBPM Stimulation
n=9 participants at risk
The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Implant site pain
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
Musculoskeletal and connective tissue disorders
Increased pain
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
General disorders
Pain other than at implant site
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
0.00%
0/9 • Throughout trial up to one year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
0.00%
0/9 • Throughout trial up to one year
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
Injury, poisoning and procedural complications
Device Migration
|
28.6%
2/7 • Number of events 2 • Throughout trial up to one year
|
44.4%
4/9 • Number of events 4 • Throughout trial up to one year
|
|
Musculoskeletal and connective tissue disorders
Collateral Muscle Stimulation
|
0.00%
0/7 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
Skin and subcutaneous tissue disorders
Edema/Swelling
|
57.1%
4/7 • Number of events 4 • Throughout trial up to one year
|
22.2%
2/9 • Number of events 2 • Throughout trial up to one year
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
33.3%
3/9 • Number of events 3 • Throughout trial up to one year
|
|
Nervous system disorders
fall
|
57.1%
4/7 • Number of events 4 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
Gastrointestinal disorders
Nausea, vomiting
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
33.3%
3/9 • Number of events 3 • Throughout trial up to one year
|
|
Infections and infestations
Flu, shingles
|
14.3%
1/7 • Number of events 1 • Throughout trial up to one year
|
11.1%
1/9 • Number of events 1 • Throughout trial up to one year
|
|
General disorders
general complaints
|
42.9%
3/7 • Number of events 3 • Throughout trial up to one year
|
66.7%
6/9 • Number of events 6 • Throughout trial up to one year
|
|
Nervous system disorders
Spasticity, hang grip issues
|
28.6%
2/7 • Number of events 2 • Throughout trial up to one year
|
33.3%
3/9 • Number of events 3 • Throughout trial up to one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60