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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVeterans Medical Research Foundation

About 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.

Eligibility criteria

Qualifiers

Male or female

Veteran or active military personnel

Between the ages of 18 and 65 years old

Served in the Persian Gulf region for at least 30 consecutive days between August 1, 1990, and July 31, 1991

Disqualifiers

Children under the age of 18

Pregnant women

Individuals with cognitive/decisional impairment

Non-English speaking individuals

Trial design

Treatments tested in this trial

  • Active Repetitive Transcranial Magnetic Stimulation
  • Active Repetitive Transcranial Magnetic Stimulation
  • Active Repetitive Transcranial Magnetic Stimulation
  • Active Repetitive Transcranial Magnetic Stimulation

Treatment groups

140 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Veterans Medical Research Foundation

Lead sponsor

San Diego Veterans Healthcare System

Collaborator

Congressionally Directed Medical Research Programs

Collaborator