Overview
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:
- What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS?
- What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS?
- 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:
- Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
- Visit the clinic a total of 12 times for assessments, check ups, and treatments.
- Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
Description
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:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments)
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at \>24 and \<72 hours apart); and
- 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)
Eligibility
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