Recruiting

AtMS vs. FtMS

Sponsor:

Veterans Medical Research Foundation

Code:

NCT07301177

Conditions

Posttraumatic Peripheral Neuropathic Pain

Peripheral Neuropathy

Peripheral Neuropathy Due to Surgical Trauma

Peripheral Neuropathy Due to Physical Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous magnetic stimulation (tMS)

Sham transcutaneous magnetic stimulation (Sham-tMS)

Patient Machine Interface (PMI)

Study Details

Brief 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

Study ID

NCT07301177

Start date

Apr 30, 2025

Status verified date

Jul, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Adaptive transcutaneous magnetic stimulation (AtMS)

The adaptive transcutaneous magnetic stimulation (AtMS) arm uses a patient machine interface (PMI) to determine what intensity to set the study tMS treatments. Treatment is then performed with an active tMS coil.

active comparator: Fixed transcutaneous magnetic stimulation (FtMS)

The fixed transcutaneous magnetic stimulation (FtMS) arm uses a patient machine interface (PMI) to determine an intensity which is then multiplied by 1.5 during the first treatment session. This calculated intensity is used for every treatment session going forward, although the subject will still engage with the PMI every session. Treatments are performed using an active tMS coil.

sham comparator: Sham transcutaneous magnetic stimulation (Sham-tMS)

The sham transcutaneous magnetic stimulation (Sham-tMS) arm uses the patient machine interface (PMI) to determine the intensity to set the study tMS treatments for each visit. Treatment is performed using a sham tMS coil that sounds and feels the same.

Interventions

Transcutaneous magnetic stimulation (tMS)

Active tMS will be given at different PTP-NP sites with an active tMS coil.

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.

Patient Machine Interface (PMI)

The PMI will be used to help determine intensities for tMS treatments.

Primary outcome measure

  • Neuropathic Pain Rating [ Time Frame: From enrollment to the end of treatment at 20 weeks ]
  • Mood [ Time Frame: From baseline to the end of treatment at 20 weeks ]
  • Quality of Life (Sleep Interference) [ Time Frame: From enrollment to the end of treatment at 20 weeks ]
  • Functionality - Absenteeism [ Time Frame: From baseline to the end of treatment at 20 weeks ]
  • Functionality - Presenteeism [ Time Frame: From baseline to the end of treatment at 20 weeks ]
  • Functionality - Overall work Productivity Impairment [ Time Frame: From baseline to the end of treatment at 20 weeks ]
  • Functionality - Activity Impairment [ Time Frame: From baseline to the end of treatment at 20 weeks ]

Central Contacts and Locations

Central contacts

Brandon C Guarini, M.A.

8586423146brandon.guarini@va.gov

Caleb T Lopez, B.S.

8585528585caleb.lopez@va.gov

Locations

Veterans Medical Center - San Diego

Recruiting

San Diego, California, United States, 92161

Contacts

Brandon C Guarini, M.A.

858-642-3146brandon.guarini@va.gov

Caleb T Lopez, B.S.

8585528585caleb.lopez@va.gov

Principal Investigator:

Albert Y Leung, M.D.

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Dec 24, 2025

Last verified

Jul, 2025

Keywords

  • adaptative transcutaneous magnetic stimulation (AtMS)
  • fixed transcutaneous magnetic stimulation (ftMS)
  • transcutaneous magnetic stimulation (tMS)
  • peripheral neuropathy
  • neuropathy
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2025-12-24.