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NCT00567541 · ClinicalTrials.gov registry record · Phase 2
An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
A Phase 2 study, sponsored by Bioness.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00567541: Completed Phase 2 study, sponsored by Bioness.
NCT00567541 is a Phase 2 study that has completed, run by Bioness. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00567541, a Phase 2 study, has completed, sponsored by Bioness.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Primary Outcome
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'.
Interventions
- DEVICE Battery Powered Microneuromodulator (BBPM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT00567541 record still lists
NCT00567541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Battery Powered Microneuromodulator (BBPM) is the first listed.
NCT00567541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00567541 about?
NCT00567541 is a clinical study titled "An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects". The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimul...
What is the current status of trial NCT00567541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2007-06. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00567541?
The interventions under investigation include: Battery Powered Microneuromodulator (BBPM) (DEVICE).
Who is sponsoring clinical trial NCT00567541?
This trial is sponsored by Bioness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00567541's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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