Adaptive transcutaneous magnetic stimulation for posttraumatic peripheral neuropathic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.