Actively Recruiting
Mechanisms of Stimulation for Pain Alleviation in Chronic Neuropathic Pain
Led by Stanford University · Updated on 2025-10-02
148
Participants Needed
1
Research Sites
13 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
Researchers are evaluating treatment options for adults with chronic neuropathic pain in the lower back, pelvis, or lower extremities. The study compares conventional medical management (CMM) alone with a combination of CMM and peripheral nerve stimulation therapy (PNS+CMM). The goal is to understand treatment effects and response rates between the control and device intervention groups in this phase 3 randomized controlled trial sponsored by Stanford University. Participants will be assigned randomly to either receive conventional medical care alone or combined with one of two FDA-approved peripheral nerve stimulation devices. The SPR SPRINT system is a wearable stimulator used for 60 days, controlled by a small remote, while the Nalu PNS System is a micro-implantable device powered externally and controlled via an app. Those in the CMM-only group will continue standard medical management without device therapy. During the study, participants will track their pain intensity daily using a numeric rating scale over three days at baseline and again at month 3 to measure treatment response defined as 50% pain relief. Additional assessments include trial response rates within 15 days. Participants must complete online questionnaires and undergo quantitative sensory testing with restrictions on physical activity, medication, and substance use around testing times. The study aims to monitor safety and effectiveness over several months, with enrollment starting in September 2025 and ending by November 2028.
CONDITIONS
Brief Title
Mechanisms of Stimulation for Pain Alleviation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older
- Clinically diagnosed unilateral chronic neuropathic pain in the lower back, pelvis, or lower extremities
- Pain caused by a peripheral nerve lesion with pain distribution matching the affected nerve
- Positive response of at least 50% pain relief to diagnostic nerve block(s)
- Chronic pain lasting at least 6 months with neuropathic pain more prominent than nociceptive pain
- Referred for or have an existing order for peripheral nerve stimulation therapy prior to enrollment
- Fluent in English reading, writing, and speaking
- Able and willing to complete online assessments
- Willing to refrain from physical activity for 7 days after lead placement
- Willing to avoid physical activity causing soreness, illicit drugs for 12 hours, PRN pain meds for 12 hours, and alcohol and nicotine on the day of quantitative sensory testing
You will not qualify if you...
- Conditions preventing completion of assessments (education, cognitive, mental, or medical status)
- Active cancer or malignant neoplasm
- Painful polyneuropathy from other causes (metabolic, autoimmune, infectious, etc.)
- Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
- Peripheral vascular disease
- Diabetic neuropathy
- Other pain diagnoses affecting study sites that may interfere with evaluation
- Presence of other active implantable devices (e.g., pacemaker, spinal cord stimulator)
- Pregnancy, breastfeeding, or planning to conceive
- Systemic or local infection at proposed implant site
- Immunocompromised state
- Blood clotting disorders or active anticoagulation
- Recent interventional procedure or surgery for neuropathic pain within 30 days
- Untreated substance use disorder
- Participation in another clinical trial with active treatment
- Numbness or sensory loss in hands or bilateral thumbnails
- History of Raynaud's Syndrome
- High blood pressure (SBP ≥150 or DBP ≥100)
- Specific contraindications for MRI or PET imaging including metal implants, claustrophobia, or pregnancy for those undergoing imaging studies
- Inability to communicate or understand study questionnaires effectively during imaging procedures if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 60 days
Participants receive peripheral nerve stimulation through FDA-approved devices designed to reduce pain by sending electrical pulses to the nerve. The stimulation period lasts for 60 days before device removal.
Regular visits for device management during the 60-day stimulation period
Duration - Up to 3 months
Participants receive conventional medical management or peripheral nerve stimulation combined with conventional care to alleviate chronic neuropathic pain.
Visits as scheduled for treatment and assessments during the study period
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
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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