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Machine Learning to Guide rTMS for Gulf War Illness Headaches and Pain

This study is testing a new way to improve treatments for headaches and body pain related to Gulf War Illness (GWI) using a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS). Researchers are using machine learning (a type of artificial intelligence) to predict which rTMS treatment will work best for each person. All participants will receive active rTMS. The study aims to see if this approach can reduce pain intensity, improve headache and pain symptoms, and help with mood. You may be able to join if you are a veteran or active military personnel between 18 and 65 years old, served in the Persian Gulf region in 1990-1991, and meet the CDC criteria for GWI. The study plans to enroll 140 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 140 veterans or active military personnel. Participants will be randomly assigned to one of four groups receiving different rTMS treatments.
What's involved
You would have 15 visits to the VA San Diego Healthcare System (VASDHS) over 3-4 months, including screening, baseline assessments, 10 rTMS treatment sessions, and three follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 months after their final treatment session, with assessments at 1 week, 1 month, and 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07325513

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

Recruiting
NAAges 18–65InterventionalTreatment
Veterans Medical Research Foundation
~140 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Active Repetitive Transcranial Magnetic Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Intensity - Mechanical Visual Analogue Scale (M-VAS)
Measured over From baseline to the end of treatment at 16 weeks
+15 more outcomes measured

Conditions

Gulf War Illness
Headache
Muscle and Joint Pain

Explore related trials

Gulf war syndromeMigraine

Where it's being run

1 sites across 1 states
California1

Who to contact

Albert Y Leung, MD
[email protected]
8585528585 · ext. 3866
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pain Intensity - Mechanical Visual Analogue Scale (M-VAS)From baseline to the end of treatment at 16 weeks

    A scale that ranges from 0 to 10 ("No pain" to "Worst possible pain").

  • Headache and Pain LogFrom enrollment to the end of treatment at 16 weeks

    A personal daily log is used to track the subject's headaches, muscle and joint pain throughout the course of the study based on a range of 0 to 10, with higher scores indicating more severe pain.

  • Mood - Hamilton Rating Scale for Depression (HRSD)From baseline to end of treatment at 16 weeks

    This scale is a well-established questionnaire which consists of twenty-one questions and rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Only the first 17 items are used for the overall scoring. A score between 14 and 18 represents a moderate form of depression and a score greater than 19 represents severe depression.

  • Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)Baseline, 1-week, 1-month, 2-months

    This is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. The BPI-sf consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine"). Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes"). Items 3-6 are summed together for a total average pain severity score.

  • Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)Baseline, 1-week, 1-month, 2-months

    This is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. The BPI-sf consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine"). Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes"). Items 9A-9G are summed together for a total pain interference score.

  • Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)Baseline, 1-week, 1-month, 2-months

    This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle pain. The SF-MPQ consists of fifteen questions; items 1-11 are measured on a 4-point response scale ranging from 0 to 3 ("None" to "Severe"). Items 12-15 include a visual analogue scale (VAS) from "No pain" to "Worst possible pain" and Present Pain Intensity (PPI) ranging from 0 to 5 ("No pain" to "Excruciating") ranking overall pain intensity for a total average muscle pain score. This is calculated via the average VAS scores (0-100) with 0 indicating no pain and 100 equivalent to the worst pain possible.

  • Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ)Baseline, 1-week, 1-month, 2-months

    This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of joint pain. The SF-MPQ consists of fifteen questions; items 1-11 are measured on a 4-point response scale ranging from 0 to 3 ("None" to "Severe"). Items 12-15 include a visual analogue scale (VAS) from "No pain" to "Worst possible pain" and Present Pain Intensity (PPI) ranging from 0 to 5 ("No pain" to "Excruciating") ranking overall pain intensity for a total average joint pain score. This is calculated via the average VAS scores (0-100) with 0 indicating no pain and 100 equivalent to the worst pain possible.

  • Functionality - Revised Fibromyalgia Impact QuestionnaireBaseline, 1-week, 1-month, 2-months

    A questionnaire to evaluate the function, overall impact and symptoms of Fibromyalgia. The 3 categories are calculated by the sum of the scores to produce a total score. Each item ranges from 0-10 and the total score is 0-100 with high scores indicating more severe impact.

  • Pain Intensity - New Clinical Fibromyalgia Diagnostic Criteria - Part 1Baseline, 1-week, 1-month, 2-months

    Patients will be asked to rate the average (over the past week) intensity of muscle pain up to 12 locations of the body. This is calculated by the Widespread Pain Index (WPI) total score ranging from 0 to 19 and a marker visual analogue scale (MVAS) ranging from 0 to 100.

  • Pain Severity - Headache Impact Test (HIT-6)Baseline, 1-week, 1-month, 2-months

    This test measures how impact headaches affect the individual's ability to function in different domains. This six question test evaluates the severity of headache pain from "Never" to "Always" with a total range between 36-78, higher scores indicating greater impact on functionality.

  • Pain Severity - Neurobehavioral Symptoms Inventory (NSI)Baseline, 1-week, 1-month, 2-months

    This twenty-two self-report questionnaire on the severity of each symptom is measured using a 5-point response scale ranging from 0 to 4 ("None - Rarely if ever present; not a problem at all" to "Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help"). It asks the subjects to indicate the extent to which each symptom has disturbed them. The total score ranges from 0 to 88 with a higher score indicating very severe symptom disruption.

  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)Baseline, 1-week, 1-month, 2-months

    This index has nineteen individual items which are used to generate 7 composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 7 components measure sleep habits and sum together to measure global sleep quality with a high score of 0-21 with a higher score indicating worse sleep quality.

  • Sleep Severity - Insomnia Severity IndexBaseline, 1-week, 1-month, 2-months

    This index consists of seven questions that depict the severity of sleep difficulties within the past 2 weeks on a 5-point response scale that rates satisfaction, noticeability, distress, and interference with daily functioning. A score between 15 and 21 suggests moderately severe clinical insomnia. A score of 22 or greater represents severe clinical insomnia.

  • Quality of Life - Veteran RAND 36-item Health Survey (VR-36+PCS and MCS)Baseline, 1-week, 1-month, 2-months

    A patient-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health.

  • Multidimensional Fatigue InventoryBaseline, 1-week, 1-month, 2-months

    A twenty item self-report instrument with 4 categories total designed to measure fatigue level (24-96) with a higher score indicating more severe fatigue.

  • Chronic Fatigue Severity ScaleBaseline, 1-week, 1-month, 2-months

    A Likert scale consisting of nine items that assess fatigue severity and functionality. The sum of all questions provides total fatigue level 8-63 with a higher score being more severe. A score over 36 indicates patient may be suffering from fatigue.