NCT07301177 DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
| NCT ID | NCT07301177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Veterans Medical Research Foundation |
| Condition | Posttraumatic Peripheral Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-04-30 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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? 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.
Eligibility Criteria
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
Contact & Investigator
Albert Y Leung, M.D.
PRINCIPAL INVESTIGATOR
Veterans Medical Research Foundation (VMRF)
Frequently Asked Questions
Who can join the NCT07301177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Peripheral Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07301177 currently recruiting?
Yes, NCT07301177 is actively recruiting participants. Contact the research team at brandon.guarini@va.gov for enrollment information.
Where is the NCT07301177 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT07301177 clinical trial?
NCT07301177 is sponsored by Veterans Medical Research Foundation. The principal investigator is Albert Y Leung, M.D. at Veterans Medical Research Foundation (VMRF). The trial plans to enroll 180 participants.