Mechanisms of Stimulation for Pain Alleviation

Phase 3

Recruiting

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

• Registration Number: NCT06741579
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-19
• Status Verified: 2025-09
• Study Start: 2025-09-26
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-10-02
• Primary Completion: 2028-08
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

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 iif 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	Baseline to Month 3	We will compare the mean of a three-day diary of numeric rating scale of pain (NRS) intensity scores (0-10 scale) at baseline to the mean of a three-day diary of NRS scores at 3 months comparing all participants randomized to CMM vs. PNS+CMM.

Secondary Outcome Measures

Name	Time	Method
Trial Response Rate	Baseline to 15 days	Defined as 50% relief of average pain intensity comparing the mean of a three-day diary of NRS scores at baseline to the mean of a three-day diary of NRS scores at 15 days comparing participants randomized to CMM vs. PNS+CMM. This outcome will be assessed either 15 days after baseline assessments among participants randomized to CMM, 15 days after Nalu PNS trial lead placement, or 15 days after SPR Sprint PNS microlead placement.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States