Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
NCT ID: NCT07325513
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2026-01-31
2029-09-30
Brief Summary
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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.
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Detailed Description
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Group A: Predicted Respondent at Left DLPFC Group B: Predicted Non-respondent at Left DLPFC Group C: Predicted Respondent at Left DLPFC and LMC Group D: Predicted Non-respondent at Left DLPFC and LMC
Participation in this study will require 15 total visits to the VASDHS over the course of 3-4 months. The visits will be separated in the following phases:
1. Pre-Treatment Assessments Phase (Weeks 1-2): Visit 1 (Screening) and Visit 2 (Baseline Assessments)
2. Induction Treatment Phase (Weeks 2-4): Visits 3-12 (Weekday active rTMS sessions at \>24 hours and \<72 hours apart)
3. Follow-Up and Maintenance Phase (Weeks 5-10): Visit 13 (1 week follow-up); Visit 14 (1 month follow-up); Visit 15 (2 months follow-up); All maintenance visits follow the final treatment of the induction phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Predicted Respondent at LDLPFC
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
Group B: Predicted Non-respondent at LDLPFC
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
Group C: Predicted Respondent at LDLPFC and LMC
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
Group D: Predicted Non-respondent at LDLPFC and LMC
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
Interventions
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Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
rTMS will be administered to the LDLPFC and LMC with an active coil.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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San Diego Veterans Healthcare System
FED
Veterans Medical Research Foundation
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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H2500180
Identifier Type: -
Identifier Source: org_study_id
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