DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
Veterans Medical Research Foundation
180 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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
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Interventions
Active tMS will be given at different PTP-NP sites with an active tMS coil.
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.
The PMI will be used to help determine intensities for tMS treatments.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07301177