NCT07301177 · Veterans Medical Research Foundation
DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
(PTP-NP)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
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
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
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.
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
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations