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
N/A
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
Researchers are investigating a machine learning approach to improve repetitive transcranial magnetic stimulation (rTMS) treatments for veterans and active military personnel experiencing headaches and body pain related to Gulf War Illness (GWI). The study aims to develop and test a Support Vector Machine (SVM) model that uses brain imaging data to predict which rTMS treatment protocol will be most effective for each individual, potentially replacing the current trial-and-error method. The main questions focus on whether the SVM model can better predict treatment response when rTMS is applied to specific brain areas in predicted responders compared to non-responders. Participants will receive a total of 13 active rTMS treatment sessions over about 3 to 4 months. They will be randomly assigned to one of four groups based on predicted response and treatment location: left dorsolateral prefrontal cortex (DLPFC) only or both left DLPFC and left motor cortex (LMC). The study includes three phases: pre-treatment assessments during the first two weeks, induction treatment phase with active rTMS sessions on weekdays spaced 24 to 72 hours apart during weeks 2 to 4, followed by a follow-up and maintenance phase with visits at 1 week, 1 month, and 2 months after treatment ends. During the 15 total clinic visits, participants will undergo assessments including brain imaging and clinical evaluations, keep a daily log of headaches and muscle and joint pain, and complete questionnaires measuring pain intensity, mood, sleep quality, fatigue, and quality of life. Researchers will monitor these outcomes from baseline through the end of treatment at 16 weeks. Safety and medication use will also be tracked. The study aims to better understand and predict individual responses to rTMS treatment to improve care for GWI-related pain symptoms.
CONDITIONS
Brief 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, with symptoms starting during or after the 1990-1991 deployment and lasting at least 6 months
- Meets the Kansas Criteria for Gulf War Illness, with moderate or multiple symptoms in at least 3 of 6 symptom categories for at least 6 months
- 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 at least one headache attack per week lasting over 1 hour in the past 3 months
- Meets International Headache Society criteria for migraine headache without aura
You will not qualify if you...
- Under 18 years old
- Pregnant women
- Cognitive or decisional impairment
- Non-English speaking
- Prisoners of War or incarcerated individuals
- VA employees or students of the institution or investigator
- Patients with cancer
- History of pacemaker implant
- Presence of ferromagnetic material in body prohibiting MRI
- History of dementia, major psychiatric or life-threatening diseases
- Other chronic neuropathic pain conditions
- Moderate to severe osteoarthritis or rheumatologic joint pain before Gulf War deployment
- Mechanical low back pain conditions
- Concurrent conditions like lupus mimicking Gulf War Illness
- History of seizure
- Pending litigation
- History of traumatic brain injury-related headaches
- Chronic tension or cluster headaches (except occasional tension headaches less than every 3 months)
- Ongoing cognitive rehabilitation or PTSD treatment
- Recent exacerbation of anxiety, substance dependence, psychotic symptoms, or suicidal ideation or attempts
- Use of narcotic analgesics, topical analgesics, steroids, local anesthetics, anticonvulsants, or antipsychotics less than 7 days before pretreatment
- Use of non-pharmacologic pain treatments during study
- Use of rescue medication other than acetaminophen up to 3g per day
- Received rTMS within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants complete baseline assessments before starting treatment.
1 visit (in-person)
Duration - 2 to 3 weeks
Participants receive active repetitive transcranial magnetic stimulation (rTMS) treatments targeting specific brain areas based on group assignment.
10 visits on weekdays, each session spaced more than 24 hours and less than 72 hours apart
Duration - 6 weeks
Participants attend follow-up visits to monitor pain, mood, and quality of life after the treatment phase.
3 visits at 1 week, 1 month, and 2 months after treatment completion
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
C
Caleb Lopez, BS
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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