NCT07301177

DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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)

Conditions

• Posttraumatic Peripheral Neuropathic Pain
• Peripheral Neuropathy
• Peripheral Neuropathy Due to Surgical Trauma
• Peripheral Neuropathy Due to Physical Trauma

Interventions

Type	Name	Description
DEVICE	Transcutaneous magnetic stimulation (tMS)	Active tMS will be given at different PTP-NP sites with an active tMS coil.
DEVICE	Sham 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.
DEVICE	Patient Machine Interface (PMI)	The PMI will be used to help determine intensities for tMS treatments.

Timeline

• Start date: 2025-04-30
• Primary completion: 2028-11-01
• Completion: 2029-03-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study