AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
Veterans Medical Research Foundation
Summary
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.
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: 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceTranscutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
- DeviceSham transcutaneous magnetic stimulation (Sham-tMS)
Sham-tMS will be given at different PTP-NP sites with a sham tMS coil. All parameters of the treatment will appear identical to the active treatment.
- DevicePatient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
Location
- Veterans Medical Center - San DiegoSan Diego, California