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Battery Powered Microneuromodulator · 1 trial · 1 indication
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'.
| Arm | Type | Description |
|---|---|---|
| Active BBPM stimulation | ACTIVE_COMPARATOR | Therapeutic Stimulation is applied via the Battery Powered Microneuromodulator (BBPM) which is programmed to deliver set stimulation parameters with approximate frequency of 30 Hz, current 5mA for 200 microseconds for the first 12 weeks of the study. The BBPM is implanted near the axillary nerve within the quadrilateral space. |
| Sham BBPM stimulation | PLACEBO_COMPARATOR | The Battery Powered Microneuromodulator is implanted near the axillary nerve within the quadrilateral space. The 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 over a 12 week period. |
| Name | Type | Description |
|---|---|---|
| Battery Powered Microneuromodulator (BBPM) | DEVICE | The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo). |
Inclusion Criteria: * 18 years of age or older * Chronic post-stroke duration greater than or equal to 6 months * Unilateral hemiplegic shoulder pain persisting for ≥6 months * Hemiparesis (shoulder abduction graded \<5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has...
Battery Powered Microneuromodulator is an investigational implantable device being studied for the treatment of chronic shoulder pain. It is specifically being evaluated in patients with chronic post-stroke shoulder pain. The device is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Battery Powered Microneuromodulator is being developed by Bioventus Inc., a company traded on the stock exchange under the ticker symbol BVS. The company is conducting clinical research to evaluate the safety and effectiveness of this investigational device for chronic shoulder pain.
Battery Powered Microneuromodulator is in Phase 2 clinical development. It is an investigational device, meaning it has not been approved by the FDA or other regulatory agencies. The device is being studied for its potential to treat chronic shoulder pain in patients who have had a stroke.
Battery Powered Microneuromodulator has one completed Phase 2 clinical trial registered as NCT00567541. This trial, titled 'An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects,' enrolled 16 participants in the United States. The study was randomized, double-blind, and placebo-controlled.
No, Battery Powered Microneuromodulator is not FDA approved. It is an investigational device currently in Phase 2 clinical development. The device is being studied for chronic shoulder pain, but it has not yet received regulatory approval for commercial use.