Peripheral Nerve Stimulation for Neuropathic Pain
(M-SPA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This is a mechanistic randomized controlled trial of 134 patients with lower extremity chronic neuropathic pain randomized to stable conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). All participants will undergo baseline and monthly remote assessments for up to 1 year. Quantitative sensory testing (QST) will be performed in all participants at baseline, 30 days, and 3 months, with an additional QST session in PNS implanted patients at 6 months. The local expression of sigma-1 receptors in chronic pain allows for visualization of peripheral pain generators, and the investigators will utilize a novel PET radiotracer highly selective for the sigma-1 receptor correlating with local receptor density and pain symptoms. 78 patients (39 in each arm, only at Stanford) will undergo \[18F\]FTC-146 PET/ MRI at baseline. 5 patients will also receive PET/CT of the lower extremities at baseline. These 78 patients will also receive \[18F\]FTC-146 PET/CT at 3 months. The investigators will characterize treatment interactions with participant attributes and baseline QST pain sensitivity measures in predicting treatment response; examine depression and physical function as mediators of treatment response; compare longitudinal pain, depressive symptom, pain catastrophizing, physical function, and QST trajectories across treatments, compare acute QST responses to PNS after stable implantation, and determine whether peripheral imaging markers correlate with baseline pain and treatment response.

Eligibility Criteria

This trial is for people with chronic pain in the lower back, leg, or due to ilioinguinal neuralgia. Participants should be experiencing neuropathic pain and can commit to a year-long study with monthly check-ins and several testing sessions. It's not specified who cannot join, but typically those with conditions that could interfere with the study or their safety would be excluded.

Inclusion Criteria

I am an adult with nerve pain in one leg due to a nerve injury or condition.

Patients enrolled in this study must already have been referred for or have an existing order for PNS implant prior to consent and enrollment in this study as part of routine medical care. Must have a positive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP. Must have chronic (at least 6 months duration), intractable peripheral neuropathic pain with any nociceptive pain less prominent than neuropathic pain. Must have stable dosage of analgesic medications for at least 30 days and be willing to refrain from trialing new analgesic medications for three months after randomization. Must have worst pain intensity of ≥5/10 on the Numeric Rating Scale (NRS) of Pain at the lower extremity CNP-PI site at enrollment and <5/10 on the NRS elsewhere over the entire body. Must be fluent in English writing, reading, and speaking. Must have the ability and willingness to complete online assessments. Must be willing to refrain from physical activity or exercise causing muscle and/or joint soreness for 48 hours prior to QST, pain medications for 12 hours prior to QST, and alcohol and nicotine on the day of QST

Exclusion Criteria

I have nerve damage due to diabetes.

I have an active cancer diagnosis, either metastatic or localized.

I have long-lasting nerve pain from a spinal cord or brain injury, or multiple sclerosis.

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Participant Groups

The trial is testing if adding Peripheral Nerve Stimulation (PNS) to regular medical care helps more than just standard treatment alone for chronic neuropathic pain. Patients are randomly chosen to receive either just conventional care or combined PNS and conventional care, followed over a year.

2Treatment groups

Experimental Treatment

Active Control

Group I: Peripheral Nerve Stimulation + Conventional Medical Management (PNS+CMM)Experimental Treatment2 Interventions

Group II: Conventional Medical Management (CMM) ONLYActive Control1 Intervention