DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)

The goal of this clinical trial is to learn if adaptative transcutaneous magnetic stimulation (AtMS) works to reduce pain caused by post-traumatic peripheral neuropathic pain (PTP-NP) within Veterans and/or active duty military personnel. It will also learn about the safety of AtMS. The main questions it aims to answer are:

1. What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS?
2. What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS?
3. What are the effects of AtMS in improving mood in patients suffering from PTP NP compared FtMS and Sham-tMS?

Researchers will compare AtMS, FtMS and Sham-tMS to see if AtMS is the best form of tMS in treating PTP-NP.

Participants will undergo the following:

1. Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
2. Visit the clinic a total of 12 times for assessments, check ups, and treatments.
3. Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.

This study will be enrolling a total of 144 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of three groups:

Group A: AtMS Group B: FtMS Group C: Sham-tMS

Individual participation will consist of 12 visits to the VASDHS over the course of 5 months. The visits will be divided into the following phases:

1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments)
2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at >24 and <72 hours apart); and
3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 6-20) consists of 2 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 8 and 9), and two additional monthly post-induction treatment assessments and maintenance treatments (Visits 10 and 11) and one final study visit (Visit 12)

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