140 Participants NeededMy employer runs this trial

Repetitive Transcranial Magnetic Stimulation for Chronic Multisymptom Illness

(SVM - GWI Trial)

AY
CL
Overseen ByCaleb Lopez, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Veterans Medical Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method to improve treatments for Gulf War Illness-related headaches and body pain in veterans and active military personnel. It employs repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, to determine if it can better target and reduce symptoms. A computer model, using a machine learning algorithm, will predict which treatment method might work best for each individual. Veterans or military members who served in the Persian Gulf and have experienced persistent headaches and muscle or joint pain for at least six months might be suitable candidates. As an unphased study, this trial provides a unique opportunity to explore innovative treatment options for symptom relief.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications like narcotic-based painkillers, topical pain relievers, steroids, local anesthetics, anticonvulsants, and antipsychotics at least 7 days before the trial starts. You can only use acetaminophen as a rescue medication during the study.

What prior data suggests that repetitive transcranial magnetic stimulation is safe for treating Gulf War Illness related symptoms?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people. In one study, only 16.7% of participants experienced issues, mostly mild. The most serious issue, a seizure, occurred very rarely. Another study found that rTMS was safe and well-tolerated for people with multiple sclerosis (MS), with no lasting side effects. The most common temporary issues were tiredness and local muscle discomfort. Overall, these findings suggest that rTMS is a well-tolerated treatment option.12345

Why are researchers excited about this trial?

Researchers are excited about repetitive transcranial magnetic stimulation (rTMS) for chronic multisymptom illness because it offers a non-invasive alternative to traditional treatments like medication and psychotherapy. Unlike conventional therapies that often rely on chemical intervention, rTMS uses magnetic fields to stimulate nerve cells in the brain, potentially offering relief without the side effects of drugs. Additionally, the use of a machine learning algorithm to predict responders and non-responders is groundbreaking, as it aims to tailor treatment more precisely to individual patients, enhancing effectiveness and efficiency. This personalized approach could revolutionize how chronic multisymptom illnesses are managed, providing hope for better-targeted therapies.

What evidence suggests that this trial's treatments could be effective for Gulf War Illness related headaches and body pain?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) may help treat chronic pain, including pain from Gulf War Illness. In one study, rTMS greatly reduced pain symptoms in veterans, demonstrating its potential effectiveness. Another study found that rTMS improved results when combined with cognitive behavioral therapy, suggesting it can boost overall well-being. This treatment uses magnetic fields to stimulate brain nerve cells, which can help lessen pain and improve mood. The trial will explore the effectiveness of rTMS in different groups, such as those predicted to respond or not respond at specific brain regions. These findings suggest that rTMS could be a helpful option for managing Gulf War Illness symptoms.678910

Are You a Good Fit for This Trial?

This trial is for veterans or active military personnel aged 18-65 who served in the Persian Gulf between August 1990 and July 1991, have had moderate joint, muscle pain, and headaches for at least 6 months due to Gulf War Illness. Participants must meet specific symptom criteria related to fatigue, pain, mood/cognition.

Inclusion Criteria

I am male or female.
I have had moderate or worse joint pain in my arms or legs for at least 6 months.
* Veteran or active military personnel
See 7 more

Timeline for a Trial Participant

Pre-Treatment Assessments

Participants undergo screening and baseline assessments

2 weeks
2 visits (in-person)

Induction Treatment

Participants receive active rTMS sessions at the left DLPFC or left DLPFC and LMC

2 weeks
10 visits (in-person)

Follow-Up and Maintenance

Participants are monitored for safety and effectiveness after treatment

6 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Active Repetitive Transcranial Magnetic Stimulation
  • Machine Learning Algorithm

Trial Overview

The study tests if a machine learning model can help predict which rTMS brain stimulation treatments work best for relieving headaches and body pain from Gulf War Illness. All participants receive up to 13 sessions of active rTMS over several months.

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: Group C: Predicted Respondent at LDLPFC and LMCActive Control1 Intervention
Group II: Group A: Predicted Respondent at LDLPFCActive Control1 Intervention
Group III: Group B: Predicted Non-respondent at LDLPFCActive Control1 Intervention
Group IV: Group D: Predicted Non-respondent at LDLPFC and LMCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials
46
Recruited
5,100+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

San Diego Veterans Healthcare System

Collaborator

Trials
38
Recruited
5,500+

Citations

Effectiveness of Repetitive Transcranial Magnetic Stimulation ...

Results: Data were analyzed per intent-to-treat. Scores for depression, fatigue, and EDSS declined significantly over time (large effect sizes), ...

Efficacy of Repetitive Transcranial Magnetic Stimulation ...

We found that 10 or more sessions of rTMS combined with cognitive behavioural therapy significantly improved clinical outcomes overall (k = 3, SMD = 0.21, CIs ...

Efficacy of Repetitive Transcranial Magnetic Stimulation ...

We found that 10 or more sessions of rTMS combined with cognitive behavioural therapy significantly improved clinical outcomes overall (k = 3, ...

rTMS for the Treatment of Chronic Pain in GW1 Veterans

This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain.

Evaluating the treatment outcomes of repetitive transcranial ...

The result showed that the rTMS treatment significantly improved cognitive performance on the severe impairment battery (SIB), reduced psychiatric symptoms on ...

Low-intensity repetitive transcranial magnetic stimulation is ...

Our data indicate that 20 sessions of rTMS, delivered in an iTBS pattern over a broad cortical area, is safe, tolerable and feasible for people with MS.

Safety and tolerability of repetitive transcranial magnetic ...

Adverse events associated with rTMS were generally mild and occurred in 16.7% of subjects. Seizure was the most serious adverse event, and occurred in three ...

Effect of high frequency repetitive transcranial magnetic ...

Conclusions. High frequency rTMS is safe and effective in treatment of truncal ataxia in RRMS patients. It has a positive effect on walking speed over a short ...

Low-intensity repetitive transcranial magnetic stimulation is ...

Within participant MRI metrics, PROMs and cognitive or motor performance were unchanged over time. Conclusion Twenty sessions of rTMS is safe ...

Evaluating the safety profile of connectome-based ...

Parcel-guided rTMS is safe with no adverse, long-lasting side effects with the most common side effects as fatigue 50% and local muscle ...