Mechanisms of Stimulation for Pain Alleviation

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06741579
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Neuropathic Pain
  • Chronic Neuropathic Pain in the Low Back and Legs
  • Peripheral Nerve Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peripheral Nerve Stimulation — DEVICE
    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.
  • Conventional Care Regimen — PROCEDURE
    CMM-Only participants will receive conventional medical management for the duration of their time in the study.

Study Details

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.

Key Dates

Start date
Sep 26, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional Medical Management (CMM) ONLY
  • Experimental: Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM)

Primary Outcome Measure

Treatment Response: defined as 50% relief of average pain intensity at the area of lower back, pelvic, or lower extremity CNP. We will compare the means of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale) [ Time Frame: Baseline to Month 3 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Jennifer Hah
[email protected]
6507243193
Jennifer Hah, MD, MS (PRINCIPAL_INVESTIGATOR)

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Stanford University· Palo Alto, CA

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