Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06741579

Mechanisms of Stimulation for Pain Alleviation

Led by Stanford University · Updated on 2025-10-02

148

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Mechanisms of Stimulation for Pain Alleviation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 or older with clinically diagnosed unilateral chronic neuropathic pain in the lower back, pelvis, or lower extremities
  • Pain caused by a peripheral nerve lesion or nerve trauma, with symptoms matching the affected nerve area
  • Positive response (at least 50% pain relief) to diagnostic nerve block(s) at the pain site
  • Chronic peripheral neuropathic pain lasting at least 6 months, with neuropathic pain more prominent than any nociceptive pain
  • Patients must already have a referral or order for peripheral nerve stimulation therapy (Nalu or SPR SPRINT) before enrollment
  • Fluent in English and able to complete online assessments
  • Willingness to refrain from physical activity for 7 days after lead placement and to follow activity and substance restrictions before testing
Not Eligible

You will not qualify if you...

  • Conditions preventing completion of assessments, such as cognitive or medical issues
  • Active cancer diagnosis or malignant neoplasm
  • Painful polyneuropathy from metabolic, autoimmune, infectious, or toxic causes
  • Chronic central neuropathic pain from spinal cord injury, brain injury, or multiple sclerosis
  • Peripheral vascular disease or diabetic neuropathy
  • Other pain diagnoses affecting the study area that could interfere with results
  • Use of other active implantable devices like pacemakers or spinal cord stimulators
  • Pregnancy, breastfeeding, or planning pregnancy
  • Systemic or local infection at the implant site
  • Immunocompromised state
  • Blood clotting disorders or active anticoagulation
  • Recent interventional procedures or surgery for chronic neuropathic pain within 30 days (or 3 months for ablative treatments)
  • Untreated substance use disorder
  • Participation in another clinical trial with active treatment
  • Numbness or sensory loss in both thumbnails, peripheral neuropathy in hands, or circulatory/sensory problems in hands
  • History of Raynaud's Syndrome
  • High blood pressure with systolic ≥150 or diastolic ≥100
  • Prior radiation exposure over 2 rem in last 12 months
  • Contraindications to MRI such as pacemakers, metal fragments, or aneurysm clips
  • Claustrophobia
  • Inability to communicate with investigators or complete questionnaires
  • Positive pregnancy test for females

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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