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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. All participants will be receiving active rTMS treatment. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Jennifer Moreno Department of Veterans Affairs Medical Center
RECRUITING
San Diego
Contact Information
Primary
Albert Y Leung, MD
ayleung@health.ucsd.edu
8585528585
Backup
Caleb Lopez, BS
caleb.lopez@va.gov
8585528585
Time Frame
Start Date: 2026-03-25
Estimated Completion Date: 2029-10
Participants
Target number of participants: 140
Treatments
Active_comparator: Group A: Predicted Respondent at LDLPFC
Active_comparator: Group B: Predicted Non-respondent at LDLPFC
Active_comparator: Group C: Predicted Respondent at LDLPFC and LMC
Active_comparator: Group D: Predicted Non-respondent at LDLPFC and LMC
Related Therapeutic Areas
Sponsors
Collaborators: San Diego Veterans Healthcare System, Congressionally Directed Medical Research Programs
Leads: Veterans Medical Research Foundation

This content was sourced from clinicaltrials.gov