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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?

The goal of this clinical trial is to create a machine learning algorithm to improve active repetitive transcranial magnetic stimulation (rTMS) treatments for veterans and/or active military personnel by alleviating Gulf War Illness related headaches and body pain (GWI-HAP). This study aims to develop and validate a Support Vector Machine (SVM) model that could replace the trial-and-error process by assessing functional connectivity provided by resting state functional magnetic resonance imaging (rs-fMRI) data to predict the most effective rTMS protocol for each person. All participants will be receiving active rTMS treatment.

The main questions it intends to answer are:

1. Does the SVM model predict a more effective treatment response rate for predicted respondents undergoing active rTMS at the left dorsolateral prefrontal cortex (DLPFC) compared to predicted non-respondents?

2. Does the SVM model predict a more effective treatment response rate while undergoing active rTMS at the left dorsolateral prefrontal cortex (DLPFC) and left motor cortex (LMC) in predicted respondents compared to predicted non-respondents?

Participants will undergo the following:

1. Receive a total of 13 active rTMS treatment sessions over 3-4 months.

2. Visit the clinic for a total of 15 visits for assessments, check ups, and treatments.

3. Keep a daily log of their headaches, muscle and joint pain throughout the study.

Are You a Good Fit for This Trial?

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

What Are the Treatments Tested in This Trial?

Interventions

  • Active Repetitive Transcranial Magnetic Stimulation
  • Machine Learning Algorithm

How Is the Trial Designed?

4

Treatment groups

Active Control

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

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