Adaptive transcutaneous magnetic stimulation for posttraumatic peripheral neuropathic pain
AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
This project will try adaptive transcutaneous magnetic stimulation (AtMS) to see if it reduces post-traumatic peripheral neuropathic pain in veterans and active-duty military.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07301177 on ClinicalTrials.gov |
What this trial studies
This randomized study will enroll 144 veterans or active-duty military at the VA San Diego Healthcare System and compare three groups: adaptive tMS (AtMS), fixed tMS (FtMS), and sham tMS. Participants will receive a total of eight treatments over about 16 weeks and attend 12 clinic visits across roughly five months for assessments, induction, and maintenance sessions. Outcomes include changes in pain, physical function, and mood, along with safety monitoring. The trial uses a parallel-group design with random assignment to determine whether AtMS provides greater benefit than FtMS or sham.
Who should consider this trial
Good fit: Ideal candidates are veterans or active-duty adults (18+) with chronic peripheral neuropathic pain persisting more than four months after a traumatic or surgical event, average daily pain >3 on the NPRS, sensory signs in the affected nerve territory, and diagnostic confirmation of the lesion.
Not a fit: Patients with central neuropathic pain (for example from diabetes, HIV, chemotherapy), Complex Regional Pain Syndrome, active phantom limb pain after amputation, significant skin problems in the treatment area, concurrent major lumbar or cervical pain conditions, or who are pregnant are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, AtMS could reduce pain and improve function and mood for people with posttraumatic peripheral neuropathic pain.
How similar studies have performed: Small studies and case reports of peripheral/transcutaneous magnetic stimulation have shown some promising but limited results, so the adaptive AtMS approach is relatively novel in this specific posttraumatic veteran population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans (men or women) of any race or ethnicity who are at least 18 years of age * Chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history * Have an average daily Numerical Pain Rating Scale (NPRS) score \> 3 * At least one negative or positive sensory sign or symptom confined to innervation territory of the lesioned nervous structure * Prior diagnostic tests confirming lesion or disease explaining neuropathic Exclusion Criteria: * Pregnancy * Subjects with central neuropathic pain (ex: due to diabetic peripheral neuropathy, HIV, chemo/anti-viral therapy, carpal tunnel syndrome, post-traumatic pain classified as central rather than peripheral) * Subjects with pain due to Complex Regional Pain Syndrome * Phantom limb pain after amputation (stump pain and phantom sensation are allowed) * Subjects with skin conditions in the affected dermatome * Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment * Any subject considered at risk of suicide * Use of prohibited medications in the absence of appropriate washout periods * Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study * Heart pacemaker * Subjects with a current diagnosis of DSM-IV-TR Axis I disorder (GAD \& MDD are allowed if clinically stable) * Subjects with pending lawsuits related to injury * Subjects who have previously received either transcranial or transcutaneous magnetic stimulation therapy in the past
Where this trial is running
San Diego, California
- Veterans Medical Center - San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Albert Y Leung, M.D. — Veterans Medical Research Foundation (VMRF)
- Study coordinator: Brandon C Guarini, M.A.
- Email: brandon.guarini@va.gov
- Phone: 8586423146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.