Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07301177

Adaptive Transcutaneous Magnetic Stimulation (AtMS) for Treating Posttraumatic Peripheral Neuropathic Pain (PTP-NP) in Veterans and Active Military

Led by Veterans Medical Research Foundation · Updated on 2025-12-24

180

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether adaptive transcutaneous magnetic stimulation (AtMS) can reduce pain caused by post-traumatic peripheral neuropathic pain (PTP-NP) in Veterans and active military personnel. The study also examines the safety of AtMS and compares its effects on pain relief, function improvement, and mood enhancement against fixed tMS (FtMS) and sham tMS treatments. Researchers want to determine if AtMS is the most effective form of tMS for treating PTP-NP. Participants will be randomly assigned to one of three groups: AtMS, FtMS, or Sham-tMS. Treatments consist of 8 sessions over 16 weeks, involving a patient machine interface (PMI) to set treatment intensity. The study includes a pre-treatment assessment phase, an induction treatment phase with five weekday sessions, and a post-treatment assessment and maintenance phase with scheduled follow-up visits. Sham-tMS mimics the active treatment without therapeutic effect, while AtMS and FtMS use active coils with different intensity settings. Participants will visit the clinic 12 times over about 5 months for assessments, treatments, and check-ups. They will keep a daily diary tracking pain intensity, sleep interference, and pain medication usage. Researchers will measure neuropathic pain rating, mood, sleep interference, and different aspects of functionality from the start to end of treatment. Safety monitoring and evaluation of medication use and sensory thresholds are also included in the study.

CONDITIONS

Brief Title

DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans or active military personnel of any race or ethnicity aged 18 years or older
  • Chronic peripheral neuropathic pain lasting more than 4 months after trauma or surgery
  • Average daily pain score greater than 3 on the Numerical Pain Rating Scale
  • At least one sensory sign or symptom confined to the affected nerve area
  • Prior diagnostic tests confirming lesion or disease causing neuropathic pain
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Central neuropathic pain or pain caused by other conditions like Complex Regional Pain Syndrome
  • Phantom limb pain after amputation (stump pain and phantom sensation allowed)
  • Skin conditions in the affected area
  • Other pain such as lumbar or cervical radiculopathy that may interfere with assessment
  • Risk of suicide
  • Use of prohibited medications without proper washout
  • Participation in another clinical trial within 30 days before or during this study
  • Having a heart pacemaker
  • Current diagnosis of certain psychiatric disorders except stable generalized anxiety disorder or major depressive disorder
  • Pending lawsuits related to injury
  • Previous receipt of transcranial or transcutaneous magnetic stimulation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pre-treatment Assessments

Duration - 1 week

Participants complete baseline assessments before starting treatment.

1 visit (in-person)

Induction Treatment

Duration - 2 weeks

Participants receive transcutaneous magnetic stimulation treatments five times on weekdays with sessions spaced more than 24 and less than 72 hours apart.

5 visits (weekday, in-person)

Post-treatment Assessments and Maintenance Treatment

Duration - Approximately 15 weeks

Participants undergo post-induction assessments and receive maintenance treatments, including two biweekly visits followed by two monthly visits, concluding with a final study visit.

5 visits (in-person) over weeks 6 to 20

Trial Site Locations

Total: 1 location

1

Veterans Medical Center - San Diego

San Diego, California, United States, 92161

Actively Recruiting

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Research Team

B

Brandon C Guarini, M.A.

C

Caleb T Lopez, B.S.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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