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

Veterans Medical Research Foundation

Status

Not yet enrolling

Conditions

Muscle and Joint Pain

Gulf War Illness

Headache

Treatments

Device: Active Repetitive Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT07325513

H2500180

Details and patient eligibility

About

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:

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?
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:

Receive a total of 13 active rTMS treatment sessions over 3-4 months.
Visit the clinic for a total of 15 visits for assessments, check ups, and treatments.
Keep a daily log of their headaches, muscle and joint pain throughout the study.

Full description

This study aims to enroll a total of 140 veterans and/or active military personnel over the 4-year study period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into receiving treatments at the left DLPFC or left DLPFC and LMC, then placed into predicted respondent or non-respondent groups. They will be assigned to 1 of 4 groups:

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:

Pre-Treatment Assessments Phase (Weeks 1-2): Visit 1 (Screening) and Visit 2 (Baseline Assessments)
Induction Treatment Phase (Weeks 2-4): Visits 3-12 (Weekday active rTMS sessions at >24 hours and <72 hours apart)
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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 4 patient groups

Group A: Predicted Respondent at LDLPFC

Active Comparator group

Treatment:

Device: Active Repetitive Transcranial Magnetic Stimulation

Group B: Predicted Non-respondent at LDLPFC

Active Comparator group

Treatment:

Device: Active Repetitive Transcranial Magnetic Stimulation

Group C: Predicted Respondent at LDLPFC and LMC

Active Comparator group

Treatment:

Device: Active Repetitive Transcranial Magnetic Stimulation

Group D: Predicted Non-respondent at LDLPFC and LMC

Active Comparator group

Treatment:

Device: Active Repetitive Transcranial Magnetic Stimulation

Trial contacts and locations

Central trial contact

Albert Y Leung, MD; Caleb Lopez, BS

Data sourced from clinicaltrials.gov

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