NCT07325513

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study aims to enroll a total of 140 veterans and/or active military personnel over the 4-year study period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into receiving treatments at the left DLPFC or left DLPFC and LMC, then placed into predicted respondent or non-respondent groups. They will be assigned to 1 of 4 groups: Group A: Predicted Respondent at Left DLPFC Group B: Predicted Non-respondent at Left DLPFC Group C: Predicted Respondent at Left DLPFC and LMC Group D: Predicted Non-respondent at Left DLPFC and LMC Participation in this study will require 15 total visits to the VASDHS over the course of 3-4 months. The visits will be separated in the following phases: 1. Pre-Treatment Assessments Phase (Weeks 1-2): Visit 1 (Screening) and Visit 2 (Baseline Assessments) 2. Induction Treatment Phase (Weeks 2-4): Visits 3-12 (Weekday active rTMS sessions at \>24 hours and \<72 hours apart) 3. Follow-Up and Maintenance Phase (Weeks 5-10): Visit 13 (1 week follow-up); Visit 14 (1 month follow-up); Visit 15 (2 months follow-up); All maintenance visits follow the final treatment of the induction phase.

Conditions

• Gulf War Illness
• Headache
• Muscle and Joint Pain

Interventions

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

Timeline

• Start date: 2026-03-25
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2026-01-08
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study