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

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.

Conditions

• Gulf War Illness
• Headache
• Muscle and Joint Pain

Interventions

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.

Sponsors & Collaborators

• Veterans Medical Research Foundation

  lead OTHER

• San Diego Veterans Healthcare System

  collaborator FED

• Congressionally Directed Medical Research Programs

  collaborator FED

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-25

Primary Completion

2029-10-31

Completion

2029-10-31

FDA Device

Yes

Countries

• United States

Study Locations