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

December 22, 2025 updated by: Veterans Medical Research Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Recruiting
        • Veterans Medical Center - San Diego
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albert Y Leung, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Transcutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
Device: Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
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.
Device: Transcutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
Device: Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
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.
Device: Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Rating
Time Frame: From enrollment to the end of treatment at 20 weeks
0 is equivalent to no neuropathic pain and 10 indicates the worst possible neuropathic pain
From enrollment to the end of treatment at 20 weeks
Mood
Time Frame: From baseline to the end of treatment at 20 weeks

Hamilton Rating Scale for Depression (HRSD) an interviewed asks 21 questions about mood, sleep, appetite, and other symptoms related to depression. The interviewer rates the severity of each symptom based on a pre-defined scale of 0-4. The scores for each item are then summed to produce a total score.

The total score on the HAM-D is used to assess the severity of depression. Lower scores indicate less severe depression, while higher scores indicate more severe depression.

Typical scoring interpretations: Below 7: Absence or remission of depression; 7-17: Mild depression; 18-24: Moderate depression; 25 and above: Severe depression
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
Daily Sleep Interference Log measures how much neuropathic pain impacts the patients sleep each night. The log is ranked on a 0 to 10 scale, 0 being pain didn't interfere with sleep and 10 being pain completely interfered with sleep, with a lower score representing a better outcome.
From enrollment to the end of treatment at 20 weeks
Functionality - Absenteeism
Time Frame: From baseline to the end of treatment at 20 weeks

Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 1:

Absenteeism (the percentage of work time missed);

***Only those being employed provided answer for absenteeism***

WPAI absenteeism scores are based 2-items (2 and 4); a score cannot be calculated if there is a missing response to the corresponding item. Question 2 represents time in hours lost due to health reasons while question 4 represents the time spent working. Time lost is divided by the total time (sum of 2 and 4) and then multiplied by 100 to express as a percentage.

All WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
From baseline to the end of treatment at 20 weeks
Functionality - Presenteeism
Time Frame: From baseline to the end of treatment at 20 weeks

Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 2:

Presenteeism (the percentage of impairment experienced while at work);

***Only those being employed provided answer for presenteeism***

WPAI presenteeism scores are based on 1-item (5) which is divided by 10 and later multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item.

WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
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

Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 3:

Overall work productivity loss (an estimate of combination of absenteeism and presenteeism);

***Only those being employed provided answer for absenteeism {Q2/(Q2+Q4)}, presenteeism {Q5/10}***

WPAI overall work productivity scores are computed based on absenteeism and presenteeism scores, using the following formula, Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)], and then being multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item.

WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
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

Work Productivity and Activity Impairment Questionnaire (WPAI-SHP version 2) metric 4:

Activity impairment (the percentage of impairment in daily activities)

***Only those being employed provided answer for absenteeism, presenteeism, and overall work impairment***

WPAI activity impairment scores are based on 1-item (item 6) which is divided by 10 and later multiplied by 100 to express as a percentage; a score cannot be calculated if there is a missing response to the corresponding item.

WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
From baseline to the end of treatment at 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Medication Usage
Time Frame: From enrollment to the end of treatment at 20 weeks

Neuropathic Pain Medication Logs will measure changes in daily neuropathic pain. The log will record if daily neuropathic pain medications are used, the medication name(s), the strength(s) measured in mg, quantity measured by number of pills/sprays/etc. As well as if additional non-daily, typically OTC, pain medications were taken for neuropathy, the medication name(s), strength(s) measured in mg, quantity measured by number of pills/spray/etc.

For this outcome, increases in any medication as well as new medications will be marked as "more" and numerically described with 1; decreases will be marked as "less" and numerically described as -1; no change will result in a 0. Total change will be summed per visit and later used as a percentage of participants positive (representing an increase in medication us) or negative (decrease in medication use) change.

Any negative score will be considered a favorable outcome.
From enrollment to the end of treatment at 20 weeks
Allodynia Area Mapping (Von Frey)
Time Frame: From baseline to the end of treatment at 20 weeks
von Frey 5.18 monofilament will be used to measure/map (cm²) out an area of neuropathic allodynia. The instrument will be used by pressing them against the neuropathic pain area and marking roughly 8 points with each. Then the points will be traced on two separate translucent papers, one for each instrument, to create two rough shapes to measure the areas. The area of the shape will be measured using a Compensating Polar Planimeter.
From baseline to the end of treatment at 20 weeks
Allodynia Area Mapping (paint brush)
Time Frame: From baseline to the end of treatment at 20 weeks
Paintbrush will be used to measure/map (cm²) out an area of neuropathic allodynia. The instrument will be used by pressing them against the neuropathic pain area and marking roughly 8 points with each. Then the points will be traced on two separate translucent papers, one for each instrument, to create two rough shapes to measure the areas. The area of the shapes will be measured using a Compensating Polar Planimeter.
From baseline to the end of treatment at 20 weeks
QST Temperature Thresholds
Time Frame: From baseline to end of treatment at 20 weeks

Thermal Sensory Analyzer (Medoc Advanced Medical Systems, Minneapolis) will be used to measure cool, warm, cold, and hot temperature (°C) thresholds.

The participant will first be asked to press the button when the increasing hot temperature becomes uncomfortable. This will be done 3 times and averaged to establish a threshold for the next portion.

The thermode will heat up to the threshold temperature and remain their for a period of time. The participant will then rate their pain experienced via MVAS scale (0-10) with a 0 describing no pain and a 10 describing the worst pain experienced.

A lower pain score will represent a better outcome and a higher score will represent a worse outcome.
From baseline to end of treatment at 20 weeks
von Frey Monofilament Threshold
Time Frame: From baseline to end of the treatment at 20 weeks
Different sized von Frey monofilament (e.g, 5.18) will be used to determine the participants physical pain sensation threshold to the von Frey monofilaments. The von Frey monofilaments will pressed against the neuropathic pain area one by one from smallest to largest until the participants expresses they can feel a sensation of physical pain in the neuropathic area caused by the von Frey monofilament.
From baseline to end of the treatment at 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Medical Research Foundation

Investigators

  • Principal Investigator: Albert Y Leung, M.D., Veterans Medical Research Foundation (VMRF)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H240010
  • HT94252410300 (Other Grant/Funding Number: Department of Defense (DoD))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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