DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeterans Medical Research Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Transcutaneous magnetic stimulation (tMS)
  • Sham transcutaneous magnetic stimulation (Sham-tMS)
  • Patient Machine Interface (PMI)

Treatment groups

180 Participants
are divided into 3 treatment groups