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This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StimRouter Neuromodulation System | Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimRouter Neuromodulation System | Device | An implantable neuromodulation device that treats chronic peripheral nerve pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain from Screening through 6 Months | Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity post-implantation | Average change from baseline to month 6 post-implantation in Pain Severity score as measured through the BPI-SF | Month 6 |
| Change in Pain Interference post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain | Average change from baseline to Month 12 post-implantation measured through a NPRS scale | Month 12 |
| Change in average pain | Average change from baseline to Month 24 post-implantation measured through a NPRS scale |
Inclusion Criteria:
Exclusion Criteria:
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Up to 173 adult subjects (18 years or older) who have chronic pain of peripheral nerve origin, or other causes for which the Clinician determines StimRouter is the appropriate therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Keith McBride | Bioness Inc | Study Chair |
| Eric Grigsby, MD | Bioness Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| California Orthopedics & Spine |
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Average change from baseline to month 6 post-implantation in Pain Interference score as measured through the BPI-SF
| Month 6 |
| Change in Health-related Quality of Life | Average change from baseline to month 6 in health-related quality of life as assess by the VR-12 questionnaire | MOnth 6 |
| Change in Patient Global Impression of change | Average change from baseline to month 6 in patient global impression of change (PGIC) | Month 6 |
| Patient Treatment Satisfaction | Overall patient treatment satisfaction survey | Month 6 |
| Pain medication use | Decrease in chronic pain related medication intake at month 6 when compared to baseline | Month 6 |
| Month 24 |
| Change in Pain Severity | Average change from baseline to Month 12 post-implantation in Pain Severity measured through the BPI-SF | Month 12 |
| Change in Pain Severity | Average change from baseline to Month 24 post-implantation in Pain Severity measured through the BPI-SF | Month 24 |
| Change in Pain Interference | Average change from baseline to Month 12 post-implantation in Pain Interference measured through the BPI-SF | Month 12 |
| Change in Pain Interference | Average change from baseline to Month 24 post-implantation in Pain Interference measured through the BPI-SF | Month 24 |
| Change in Health-related Quality of Life | Average change from baseline to month 12 in health-related quality of life as assess by the VR-12 questionnaire | Month 12 |
| Change in Health-related Quality of Life | Average change from baseline to month 24 in health-related quality of life as assess by the VR-12 questionnaire | Month 24 |
| Change in Patient Global Impression of Change | Average change from baseline to month 12 in patient global impression of change (PGIC) | Month 12 |
| Change in Patient Global Impression of Change | Average change from baseline to month 24 in patient global impression of change (PGIC) | Month 24 |
| Pain Medication Use | Decrease in chronic pain related medication intake at month 12 when compared to baseline | Month 12 |
| Pain Medication Use | Decrease in chronic pain related medication intake at month 24 when compared to baseline | Month 24 |
| Larkspur |
| California |
| 94939 |
| United States |
| Stanford University | Redwood City | California | 94063 | United States |
| Stamford Hospital | Stamford | Connecticut | 06905 | United States |
| International Spine,Pain and Performance Center | Washington D.C. | District of Columbia | 20037 | United States |
| Warner Orthopedics | Baton Rouge | Louisiana | 70817 | United States |
| Albert Einstein/Moss Rehab | Elkins Park | Pennsylvania | 19027 | United States |
| Valley Sports and Spine Clinic | Blacksburg | Virginia | 24060 | United States |
| Advocate Aurora Health | Oshkosh | Wisconsin | 54904 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010523 | Peripheral Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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