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New treatment option for Gulf War Illness
Official title Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
ClinicalTrials.gov ID: NCT07325513
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- Children under the age of 18
- Pregnant women
- Individuals with cognitive/decisional impairment
- Non-English speaking individuals
- Prisoners of War
- Incarcerated individuals
See the full eligibility 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...
- 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...
- 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
- 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, people 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.