DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
PTP-NP
AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
2 other identifiers
interventional
180
1 country
1
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?
- 4.Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
- 5.Visit the clinic a total of 12 times for assessments, check ups, and treatments.
- 6.Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2025
CompletedFirst Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
December 24, 2025
July 1, 2025
3.5 years
July 9, 2025
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Neuropathic Pain Rating
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
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)
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
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
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
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
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 Outcomes (5)
Neuropathic Pain Medication Usage
From enrollment to the end of treatment at 20 weeks
Allodynia Area Mapping (Von Frey)
From baseline to the end of treatment at 20 weeks
Allodynia Area Mapping (paint brush)
From baseline to the end of treatment at 20 weeks
QST Temperature Thresholds
From baseline to end of treatment at 20 weeks
von Frey Monofilament Threshold
From baseline to end of the treatment at 20 weeks
Study Arms (3)
Adaptive transcutaneous magnetic stimulation (AtMS)
ACTIVE COMPARATORThe 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.
Fixed transcutaneous magnetic stimulation (FtMS)
ACTIVE COMPARATORThe 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 transcutaneous magnetic stimulation (Sham-tMS)
SHAM COMPARATORThe 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
Active tMS will be given at different PTP-NP sites with an active tMS coil.
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.
The PMI will be used to help determine intensities for tMS treatments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Medical Center - San Diego
San Diego, California, 92161, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Y Leung, M.D.
Veterans Medical Research Foundation (VMRF)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
December 24, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
December 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share