Adaptive Transcutaneous Magnetic Stimulation for Nerve Pain
(PTP-NP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Albert Y Leung, M.D.
Principal Investigator
Veterans Medical Research Foundation (VMRF)
Are You a Good Fit for This Trial?
This trial is for Veterans and/or active duty military personnel who are experiencing chronic nerve pain due to post-traumatic peripheral neuropathy. Participants must be able to visit the clinic 12 times over 16 weeks, receive treatments, and keep a daily diary of their pain levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Pre-treatment Assessments
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive 5 weekday tMS sessions at intervals of more than 24 and less than 72 hours apart
Post-treatment Assessments and Maintenance Treatment
Participants undergo biweekly and monthly post-induction treatment assessments and maintenance treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AtMS
Trial Overview
The study tests if adaptive transcutaneous magnetic stimulation (AtMS) can reduce nerve pain better than fixed tMS or sham-tMS. It also examines AtMS's effects on function and mood in patients with PTP-NP by comparing three different treatment approaches.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Veterans Medical Research Foundation
Lead Sponsor
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