Trials / Recruiting
RecruitingNCT06741579
Mechanisms of Stimulation for Pain Alleviation
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.
Conditions
- Chronic Neuropathic Pain in the Low Back and Legs
- Peripheral Nerve Stimulation
- Chronic Neuropathic Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Peripheral Nerve Stimulation | This trial studies 2 FDA approved peripheral nerve stimulation devices that may reduce pain by sending electrical pulses to the nerve. The SPR SPRINT PNS System, a matchbox-sized, battery-powered wearable stimulator that uses a Mircrolead to deliver stimulation for pain relief. There is a small wireless hand-held remote that is used to activate/ adjust intensity of stimulation. Stimulation delivered by this device may interrupt pain signals and increase non-pain signals. The SPR SPRINT device is used for 60 days before the percutaneous Microlead(s) are removed. The Nalu PNS System, a dime-sized micro-implantable pulse generator (IPG) leveraging advanced microelectronics. The micro-IPG is powered by an externally worn therapy disc via radiofrequency worn over the IPG site with an adhesive clip applied to the skin or a relief belt. The device is remote-controlled by patients via an app. |
| PROCEDURE | Conventional Care Regimen | CMM-Only participants will receive conventional medical management for the duration of their time in the study. |
Timeline
- Start date
- 2025-09-26
- Primary completion
- 2028-08-01
- Completion
- 2028-11-01
- First posted
- 2024-12-19
- Last updated
- 2025-10-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06741579. Inclusion in this directory is not an endorsement.