Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain

Part of paid clinical trials in San Diego, California.

Sponsor
Veterans Medical Research Foundation
Study ID
NCT07325513
Status
Recruiting
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Conditions

  • Gulf War Illness
  • Headache
  • Muscle and Joint Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Repetitive Transcranial Magnetic Stimulation — DEVICE
    rTMS will be administered to the LDLPFC with an active coil.
  • Active Repetitive Transcranial Magnetic Stimulation — DEVICE
    rTMS will be administered to the LDLPFC with an active coil.
  • Active Repetitive Transcranial Magnetic Stimulation — DEVICE
    rTMS will be administered to the LDLPFC and LMC with an active coil.
  • Active Repetitive Transcranial Magnetic Stimulation — DEVICE
    rTMS will be administered to the LDLPFC and LMC with an active coil.

Study Details

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.

Key Dates

Start date
Mar 25, 2026
Status verified
Dec 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: Predicted Respondent at LDLPFC
  • Active Comparator: Group B: Predicted Non-respondent at LDLPFC
  • Active Comparator: Group C: Predicted Respondent at LDLPFC and LMC
  • Active Comparator: Group D: Predicted Non-respondent at LDLPFC and LMC

Primary Outcome Measure

Pain Intensity - Mechanical Visual Analogue Scale (M-VAS) [ Time Frame: From baseline to the end of treatment at 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jennifer Moreno Department of Veterans Affairs Medical CenterSan DiegoCalifornia92161
Caleb Lopez, B.S.
[email protected]
8585528585
Albert Leung, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Jennifer Moreno Department of Veterans Affairs Medical Center· San Diego, CA

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