Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System |
|
| Control | Active Comparator | Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator | Device | Non-inferior comparison of implantable spinal cord stimulators |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in back pain VAS and neurological status from Baseline | The primary endpoint is a composite of effectiveness and safety. Specifically, the primary endpoint is the percentage of randomized subjects (the ITT analysis population) and subjects completing the Primary Efficacy Assessment (the PP analysis population) who respond to SCS therapy (as assessed by VAS) for back pain and do not have a stimulation-related neurological deficit at the Primary Efficacy Assessment (non-inferiority analysis). Subjects who do not have a successful Trial Phase are considered failures (non-responders) toward the primary endpoint. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disability as measured by Oswestry Disability Index | 3, 6, 12 months | |
| Number of subjects with adverse events | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonardo Kapural, MD | The Center for Clinical Research, Winston-Salem, NC | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29858746 | Derived | Amirdelfan K, Yu C, Doust MW, Gliner BE, Morgan DM, Kapural L, Vallejo R, Sitzman BT, Yearwood TL, Bundschu R, Yang T, Benyamin R, Burgher AH, Brooks ES, Powell AA, Subbaroyan J. Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT. Qual Life Res. 2018 Aug;27(8):2035-2044. doi: 10.1007/s11136-018-1890-8. Epub 2018 Jun 1. |
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided