RecruitingNot Applicable

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

United States140 participantsStarted 2026-03-25

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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. Qualifying symptoms must be at least moderate in severity and/or multiple symptoms must be present within at least 3 of 6 categories consisting of fatigue/sleep, neurological/cognitive/mood, pain, respiratory, gastroenterological, and dermatological symptomology. * Average Overall Daily Muscle Pain Intensity ≥3 on a 0-10 NPRS, present for at least 6 months * Average Overall Daily Extremities Joint Pain Intensity ≥3 on a 0-10 NPRS, present for at least 6 months * Average Headache Exacerbation Intensity ≥3 on a 0-10 NPRS, with headaches occurring for at least 6 months * Headache Exacerbation/attack ≥ 1 time per week with the average intensity ≥3 on a 0-10 NPS, lasting \> 1 hour in the past three months * International Headache Society Criteria for Mig…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses machine learning to guide rTMS treatment for Gulf War Illness pain and headaches — can you explain what that means in practice, and how different it is from standard rTMS approaches I might already be eligible for?
2Since this trial is listed as Phase NA, what does that tell us about how much is already known about the safety of this particular machine-learning-guided rTMS approach, and what uncertainties should I be prepared for?
3The study is tracking a lot of outcomes beyond just pain — things like sleep quality, fatigue, mood, and overall quality of life — does that suggest I'd be coming in frequently for assessments, and is the time commitment realistic given my current situation?
4Given that Gulf War Illness can look different from person to person, how would you and the research team use the machine learning component to tailor the rTMS sessions to my specific pattern of headaches and body pain?
5Before I consider this trial, are there standard treatments for Gulf War Illness-related headaches and chronic pain that I haven't tried yet, and would it make more sense to try those first rather than enrolling in a research study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity - Mechanical Visual Analogue Scale (M-VAS)

Timeframe: From baseline to the end of treatment at 16 weeks

Headache and Pain Log

Timeframe: From enrollment to the end of treatment at 16 weeks

Mood - Hamilton Rating Scale for Depression (HRSD)

Timeframe: From baseline to end of treatment at 16 weeks

Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)

Timeframe: Baseline, 1-week, 1-month, 2-months

Trial details

NCT IDNCT07325513

SponsorVeterans Medical Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-10

Contact for this trial

Albert Y Leung, MD

8585528585 ayleung@health.ucsd.edu

View on ClinicalTrials.gov More Gulf War Illness trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain Intensity - Mechanical Visual Analogue Scale (M-VAS)

Timeframe: From baseline to the end of treatment at 16 weeks

Headache and Pain Log

Timeframe: From enrollment to the end of treatment at 16 weeks

Mood - Hamilton Rating Scale for Depression (HRSD)

Timeframe: From baseline to end of treatment at 16 weeks

Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)

Timeframe: Baseline, 1-week, 1-month, 2-months

Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)

Timeframe: Baseline, 1-week, 1-month, 2-months