Actively Recruiting
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Led by Veterans Medical Research Foundation · Updated on 2026-04-13
140
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
V
Veterans Medical Research Foundation
Lead Sponsor
S
San Diego Veterans Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Gulf War Illness (GWI) with symptoms starting during or after the 1990-1991 deployment and present for at least 6 months
- Meets the Kansas Criteria for Gulf War Illness (GWI) with moderate or multiple symptoms in at least 3 of 6 categories
- Average daily muscle pain intensity of 3 or higher on a 0-10 scale for at least 6 months
- Average daily extremities joint pain intensity of 3 or higher on a 0-10 scale for at least 6 months
- Average headache intensity of 3 or higher on a 0-10 scale with headaches occurring for at least 6 months
- Headache attacks at least once per week lasting more than 1 hour with intensity of 3 or higher in the past 3 months
- Meets International Headache Society Criteria for Migraine Headache without aura
You will not qualify if you...
- Children under the age of 18
- Pregnant women
- Individuals with cognitive or decisional impairment
- Non-English speaking individuals
- Prisoners of War or incarcerated individuals
- VA employees, including paid, IPA, or WOC
- Students of the institution or investigator
- Patients with cancer
- History of pacemaker implant
- Presence of ferromagnetic material in the brain or body prohibiting MRI
- History of dementia, major psychiatric diseases, or life-threatening diseases
- Other chronic neuropathic pain conditions like Complex Regional Pain Syndrome or Painful Peripheral Neuropathy
- Moderate to severe osteoarthritis or rheumatologic joint pain prior to Gulf War deployment
- Low back pain with mechanical causes like lumbar radiculopathy or facet arthropathy
- Concurrent conditions such as lupus mimicking Gulf War Illness
- History of seizures
- Pending litigation
- History of traumatic brain injury-related headaches
- Chronic tension or cluster headaches, except occasional tension headaches less than once every three months
- Ongoing cognitive rehabilitation or PTSD treatment
- Recent exacerbation of anxiety, substance dependence, or current psychotic symptoms
- Ongoing suicidal or homicidal thoughts or recent suicidal attempts within 6 months
- Use of narcotic analgesics, topical analgesics, steroid or local anesthetic injections, anticonvulsants, or antipsychotic medications within 7 days before pretreatment
- Use of non-pharmacologic treatments like TENS, acupuncture, acupressure, or massage during the study
- Use of additional rescue medications other than acetaminophen up to 3g per day
- Received rTMS treatment within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jennifer Moreno Department of Veterans Affairs Medical Center
San Diego, California, United States, 92161
Actively Recruiting
Research Team
A
Albert Y Leung, MD
CONTACT
C
Caleb Lopez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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