Posttraumatic Peripheral Neuropathic PainPTP-NPNCT07301177
DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
A study testing Transcutaneous magnetic stimulation (tMS) and Patient Machine Interface (PMI) in people with Posttraumatic Peripheral Neuropathic Pain and Peripheral Neuropathy, run by Veterans Medical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Peripheral Neuropathic Pain, Peripheral Neuropathy, Peripheral Neuropathy Due to Surgical Trauma
- What is being tested?
- Transcutaneous magnetic stimulation (tMS) and Patient Machine Interface (PMI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Veterans Medical Center - San Diego
San Diego, California, 92161
Brandon C Guarini, M.A., 858-642-3146 ext. 3146, brandon.guarini@va.gov
Caleb T Lopez, B.S., 8585528585 ext. 2684, caleb.lopez@va.gov
About this study
Official title: 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:
- What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS?
- What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS?
- What are the effects of AtMS in improving mood in patients suffering from PTP NP compared FtMS and Sham-tMS?
Read more
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:
- Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
- Visit the clinic a total of 12 times for assessments, check ups, and treatments.
- Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
Read the 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:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments)
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at >24 and <72 hours apart); and
- 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)
- Conditions
- Posttraumatic Peripheral Neuropathic Pain, Peripheral Neuropathy, Peripheral Neuropathy Due to Surgical Trauma, Peripheral Neuropathy Due to Physical Trauma
- Being tested
- Transcutaneous magnetic stimulation (tMS), Sham transcutaneous magnetic stimulation (Sham-tMS), Patient Machine Interface (PMI)
- Keywords
- adaptative transcutaneous magnetic stimulation (AtMS), fixed transcutaneous magnetic stimulation (ftMS), transcutaneous magnetic stimulation (tMS), peripheral neuropathy, neuropathy, pain
- Medical subject headings
- Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous magnetic stimulation (tMS)Device
Active tMS will be given at different PTP-NP sites with an active tMS coil.
Sham transcutaneous magnetic stimulation (Sham-tMS)Device
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)Device
The PMI will be used to help determine intensities for tMS treatments.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive transcutaneous magnetic stimulation (AtMS) | Active comparator | 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. Receives: Device: Transcutaneous magnetic stimulation (tMS); Device: Patient Machine Interface (PMI) |
| Fixed transcutaneous magnetic stimulation (FtMS) | Active comparator | 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. Receives: Device: Transcutaneous magnetic stimulation (tMS); Device: Patient Machine Interface (PMI) |
| Sham transcutaneous magnetic stimulation (Sham-tMS) | Sham comparator | 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. Receives: Device: Sham transcutaneous magnetic stimulation (Sham-tMS); Device: Patient Machine Interface (PMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Rating
0 is equivalent to no neuropathic pain and 10 indicates the worst possible neuropathic pain
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to the end of treatment at 20 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to end of the treatment at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start30 Apr 2025
- Primary completionNov 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Y Leung, M.D., Principal investigator, Veterans Medical Research Foundation (VMRF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301177
- Sponsor's protocol ID
- H240010
- Other IDs
- HT94252410300
- Acronym
- PTP-NP
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)
- ClinicalTrials.gov ID
- NCT07301177
- Acronym / sponsor ID
- PTP-NP / H240010
- Conditions
- Posttraumatic Peripheral Neuropathic Pain, Peripheral Neuropathy, Peripheral Neuropathy Due to Surgical Trauma, Peripheral Neuropathy Due to Physical Trauma
- Keywords
- adaptative transcutaneous magnetic stimulation (AtMS), fixed transcutaneous magnetic stimulation (ftMS), transcutaneous magnetic stimulation (tMS), peripheral neuropathy, neuropathy, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS?
- What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS?
- 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:
- Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks.
- Visit the clinic a total of 12 times for assessments, check ups, and treatments.
- Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.
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:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments)
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at >24 and <72 hours apart); and
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptive transcutaneous magnetic stimulation (AtMS) | Active comparator | Device: Transcutaneous magnetic stimulation (tMS), Device: Patient Machine Interface (PMI)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. |
| Fixed transcutaneous magnetic stimulation (FtMS) | Active comparator | 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. |
| Sham transcutaneous magnetic stimulation (Sham-tMS) | Sham comparator | Device: Sham transcutaneous magnetic stimulation (Sham-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous magnetic stimulation (tMS)Active tMS will be given at different PTP-NP sites with an active tMS coil. | Device | Adaptive transcutaneous magnetic stimulation (AtMS), Fixed transcutaneous magnetic stimulation (FtMS) |
| 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 | Sham transcutaneous magnetic stimulation (Sham-tMS) |
| Patient Machine Interface (PMI)The PMI will be used to help determine intensities for tMS treatments. | Device | Adaptive transcutaneous magnetic stimulation (AtMS), Fixed transcutaneous magnetic stimulation (FtMS), Sham transcutaneous magnetic stimulation (Sham-tMS) |
Primary outcome
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
5 secondary outcomes
Neuropathic Pain Medication Usage
Time frame: 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
Allodynia Area Mapping (paint brush)
Time frame: From baseline to the end of treatment at 20 weeks
QST Temperature Thresholds
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Y Leung, M.D. principal investigator
Veterans Medical Research Foundation (VMRF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous magnetic stimulation (tMS) and Patient Machine Interface (PMI) in people with Posttraumatic Peripheral Neuropathic Pain and Peripheral Neuropathy, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon C Guarini, M.A. (8586423146 ext. 3146, brandon.guarini@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Rating (time frame: From enrollment to the end of treatment at 20 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.