Mechanisms of Stimulation for Pain Alleviation

Recruiting now · Phase 3

Conditions studied: Peripheral Nerve Stimulation, Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders)

In brief

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.

Key facts

Study ID

NCT06741579

Run by

Stanford University

People needed

148

Starts

2025-09-26

Expected to finish

2028-11-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
• Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
• Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
• Peripheral vascular disease
• Diabetic neuropathy
• Another pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and/or could confound evaluation of study endpoints (e.g., post-herpetic neuralgia)
• Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)
• Pregnancy, breastfeeding, or planning to conceive
• Systemic infection or local infection at the anticipated PNS implant site
• Immunocompromised state
• Coagulation disorder, bleeding diathesis, platelet dysfunction, active anticoagulation
• Interventional procedure and/or surgery to treat CNP in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure)
• Untreated substance use disorder
• Participating in another clinical trial with an active treatment arm
• Numbness or loss of sensation at the bilateral thumbnails, peripheral neuropathy in the hands, circulatory or sensory problem in the hands*
• Participants with a history of Raynaud's Syndrome*
• Participants with SBP ≥150 and/or DBP ≥100*
• QST Inclusion/Exclusion Criteria. Participants can still be enrolled if they have the QST-only exclusionary criteria have the QST-only exclusionary criteria, but QST will be modified based on responses
• Additional Exclusion Criteria for Subjects receiving PET/MRI and PET/CT imaging at Stanford:
• Prior radiation exposure of >2 rem total within the last 12 months
• Standard contraindications that would preclude MRI including pacemakers or other electronic implants, metal foreign objects or fragments in the eye or body, and aneurysm clips.
• Claustrophobia
• Inability to understand and communicate with the investigators to complete the study related questionnaires
• Females with positive pregnancy test.

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)
• The University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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