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DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

NCT07301177 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Veterans Medical Research Foundation

    lead OTHER

Principal Investigators

  • Albert Y Leung, M.D. · Veterans Medical Research Foundation (VMRF)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2028-11-30
Completion
2029-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301177 on ClinicalTrials.gov