An interventional study of Transcutaneous magnetic stimulation (tMS) and Sham transcutaneous magnetic stimulation (Sham-tMS) in Posttraumatic Peripheral Neuropathic Pain, Peripheral Neuropathy and Peripheral Neuropathy Due to Surgical Trauma, sponsored by Veterans Medical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment
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:
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:
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:
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Device: Patient Machine Interface (PMI)
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) · Device: Patient Machine Interface (PMI)
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: Sham transcutaneous magnetic stimulation (Sham-tMS) · Device: Patient Machine Interface (PMI)
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.
Neuropathic Pain Rating
0 is equivalent to no neuropathic pain and 10 indicates the worst possible neuropathic pain
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to the end of treatment at 20 weeks
Neuropathic Pain Medication Usage
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.
Time frame: From enrollment to the end of treatment at 20 weeks
Allodynia Area Mapping (Von Frey)
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.
Time frame: From baseline to the end of treatment at 20 weeks
Allodynia Area Mapping (paint brush)
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.
Time frame: From baseline to the end of treatment at 20 weeks
QST Temperature Thresholds
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.
Time frame: From baseline to end of treatment at 20 weeks
von Frey Monofilament Threshold
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.
Time frame: From baseline to end of the treatment at 20 weeks
Plan to share: No
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