Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Veterans Medical Research Foundation
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.
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 re…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Meets the CDC Criteria for GWVI (GWI), with symptoms starting during or after the 1990-1991 Persian Gulf deployment. Symptoms must be present for at least 6 months prior to enrollment in the study. Symptoms must be present in at least 2 of the 3 categories of fatigue, musculoskeletal, and mood cognitive. * Meets the Kansas Criteria for GWVI (GWI), with symptoms star…
Interventions
- DeviceActive Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
- DeviceActive Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
- DeviceActive Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
- DeviceActive Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
Location
- Jennifer Moreno Department of Veterans Affairs Medical CenterSan Diego, California