Using machine learning to guide rTMS for Gulf War Illness–related headaches and body pain
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
This trial will try using a machine learning model on resting brain scans to predict which active rTMS treatment will best reduce headaches and body pain in veterans with Gulf War Illness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07325513 on ClinicalTrials.gov |
What this trial studies
The study will enroll up to 140 veterans or active military personnel with Gulf War Illness and randomize participants to receive active rTMS targeting either the left dorsolateral prefrontal cortex (DLPFC) alone or left DLPFC plus left motor cortex (LMC). Resting-state fMRI scans will be used to derive functional connectivity measures that feed a Support Vector Machine (SVM) model to classify predicted responders and non-responders. All participants will receive active rTMS over a 2- to 3-week induction phase followed by follow-up and maintenance visits, totaling 15 visits over about 3–4 months. The primary aim is to test whether the SVM prediction improves response rates and reduces the current trial-and-error approach to selecting rTMS targets.
Who should consider this trial
Good fit: Ideal candidates are veterans or active military personnel aged 18–65 who served at least 30 consecutive days in the 1990–1991 Persian Gulf deployment and meet CDC and Kansas criteria for Gulf War Illness with ongoing headaches and musculoskeletal pain.
Not a fit: Patients without Gulf War deployment or GWI diagnostic criteria, those with contraindications to rTMS or MRI, or those with pain not related to GWI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could personalize rTMS treatment and reduce trial-and-error, leading to faster and greater relief of headache and body pain symptoms for affected veterans.
How similar studies have performed: Prior rTMS studies have shown benefit for some headache and pain conditions, but using machine learning on rs-fMRI to guide rTMS target selection is a novel and largely experimental approach with limited prior data in GWI.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Migraine Headache without aura Exclusion Criteria: * Children under the age of 18 * Pregnant women * Individuals with cognitive/decisional impairment * Non-English speaking individuals * Prisoners of War * Incarcerated individuals * VA employees - including VA paid, IPA, or WOC * Students of the institution or of the investigator * Patients with cancer * History of pacemaker implant * Presence of ferromagnetic material (e.g., bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI * History of dementia, major psychiatric diseases, or life-threatening diseases * Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy * Known diagnosis of moderate to severe osteoarthritis and/or rheumatologic joint pain prior to the GWI deployment * Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy * Concurrent conditions, like lupus, that can produce symptoms compatible with GWVI * History of seizure * Pending litigation * History of Traumatic Brain Injury-related headaches * Chronic Tension or Cluster Headache. However, subjects with occasional tension headaches (less than once every three months and lasting no more than 24 hours) will not be excluded from the study. * Ongoing Cognitive Rehabilitation or Treatment of PTSD * Recent exacerbation of anxiety disorder symptoms, active substance dependence, and/or current psychotic symptoms * Ongoing suicidal/homicidal ideation or recent (in the past 6 months) suicidal attempts * Patients who receive any narcotic-based analgesic, topical analgesics over the affected site, steroid and local anesthetic injection, anticonvulsants, and antipsychotic medications less than 7 days prior to the pretreatment assessment * Patients who do not agree to avoid use of non-pharmacologic treatments, including but not limited to, transcutaneous electrical nerve stimulation unit (TENS), acupuncture, acupressure, and therapeutic massage during the entire study. * Patients who do not agree to use additional acetaminophen (up to a maximum total of 3g per day) as the only rescue medication * Patients who have received rTMS within the past 6 months
Where this trial is running
San Diego, California
- Jennifer Moreno Department of Veterans Affairs Medical Center — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Albert Y Leung, MD
- Email: ayleung@health.ucsd.edu
- Phone: 8585528585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.