Mechanisms of Stimulation for Pain Alleviation

PHASE3RecruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

September 26, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

November 1, 2028

Conditions
Chronic Neuropathic Pain in the Low Back and LegsPeripheral Nerve StimulationChronic Neuropathic Pain
Interventions
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.

Trial Locations (1)

94304

RECRUITING

Stanford University, Palo Alto

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

University of Kansas Medical Center

OTHER

lead

Stanford University

OTHER

NCT06741579 - Mechanisms of Stimulation for Pain Alleviation | Biotech Hunter | Biotech Hunter