RecruitingPhase 3NCT06741579

Mechanisms of Stimulation for Pain Alleviation


Sponsor

Stanford University

Enrollment

148 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Conventional Care Regimen and a medical device called Peripheral Nerve Stimulation for people with chronic neuropathic pain, chronic neuropathic pain in the low back and legs, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPeripheral 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.

PROCEDUREConventional Care Regimen

CMM-Only participants will receive conventional medical management for the duration of their time in the study.


Locations(2)

Stanford University

Palo Alto, California, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT06741579


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