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?
This trial aims to determine if a new treatment, adaptive transcutaneous magnetic stimulation (AtMS), can reduce nerve pain from injuries or surgeries. Researchers will compare AtMS with other methods to identify the most effective for pain relief, improving function, and boosting mood. The trial includes treatments over 16 weeks and requires participants to maintain a daily diary of pain and sleep patterns. Veterans or active duty military members with nerve pain from past injuries or surgeries may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could lead to new pain relief options.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications, but it mentions that the use of prohibited medications requires appropriate washout periods (time without taking certain medications). It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What prior data suggests that adaptive transcutaneous magnetic stimulation (AtMS) is safe for treating nerve pain?
Studies have shown that transcranial magnetic stimulation (TMS) is generally well-tolerated. In research on magnetic stimulation, most patients reported no serious side effects. Previous studies have demonstrated that adaptive transcutaneous magnetic stimulation (AtMS) is safe and does not cause significant adverse effects.
Fixed transcutaneous magnetic stimulation (FtMS) shows similar results. A study on a related type of magnetic nerve stimulation found that participants experienced significant pain relief without major safety concerns.
Both AtMS and FtMS have good safety records, with no severe side effects commonly reported. This makes them promising options for managing nerve pain. Always discuss potential risks with a healthcare provider before joining any trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about adaptive transcutaneous magnetic stimulation (AtMS) for nerve pain because it offers a personalized approach that adjusts treatment intensity based on patient feedback. Unlike traditional treatments that use medications like pain relievers or nerve blockers, AtMS utilizes magnetic pulses to target nerve pathways. This non-invasive method could potentially reduce side effects and provide quicker relief. The fixed transcutaneous magnetic stimulation (FtMS) is another approach being explored, offering a more consistent treatment intensity throughout sessions. Lastly, the sham transcutaneous magnetic stimulation (Sham-tMS) serves as a control, helping to evaluate the true effectiveness of these innovative techniques.
What evidence suggests that this trial's treatments could be effective for nerve pain?
This trial will compare adaptive transcutaneous magnetic stimulation (AtMS) with fixed transcutaneous magnetic stimulation (FtMS) and a sham treatment. Research shows that AtMS might reduce nerve pain more effectively than other methods. Previous studies found that a similar technique, repetitive transcranial magnetic stimulation (rTMS), lowered pain levels by an average of 38.8 on a visual scale. This suggests that AtMS could effectively ease pain from post-traumatic peripheral neuropathic pain (PTP-NP). Meanwhile, FtMS, another method under study in this trial, has also been tested and significantly reduced pain in some patients. For example, one study found that over 60% of patients experienced a major decrease in pain with similar magnetic treatments. These findings offer promising evidence that both AtMS and FtMS can help manage nerve pain.12346
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
Citations
DoD AtMS for Posttraumatic Peripheral Neuropathic Pain
The goal of this clinical trial is to learn if adaptative transcutaneous magnetic stimulation (AtMS) works to reduce pain caused by post- ...
Neuropathic Pain Relief Through Transcutaneous Electrical ...
Overall, TENS slightly reduced neuropathic pain compared to placebo, but this was not clinically significant (SMD = −0.35; 95% CI: −0.90 to 0. ...
Adaptive Transcutaneous Magnetic Stimulation for Nerve ...
The study tests if adaptive transcutaneous magnetic stimulation (AtMS) can reduce nerve pain better than fixed tMS or sham-tMS.
4.
frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.786225/fullDifference in Analgesic Effects of Repetitive Transcranial ...
Migita et al. (1995) reported the pain-relieving effects of repetitive transcranial magnetic stimulation (rTMS) in two patients with central ...
Repetitive transcranial magnetic stimulation focusing on ...
Based on the results of our previous randomized controlled trial, the average reduction in VAS pain intensity was 38.8 for active rTMS. The ...
Effects of multiple transcranial magnetic stimulation ...
In total, 193 patients completed test period of 4 rTMS sessions and 42% of them reported a pain relief (PR) greater than 30%, with concurrent ...
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