Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVeterans Medical Research Foundation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children under the age of 18
Pregnant women
Individuals with cognitive/decisional impairment
Non-English speaking individuals
Trial design
Design model
Parallel
Treatments tested in this trial
Active Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be administered to the LDLPFC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be administered to the LDLPFC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be administered to the LDLPFC and LMC with an active coil.
Active Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be administered to the LDLPFC and LMC with an active coil.
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: Group A: Predicted Respondent at LDLPFCActive comparator 1 intervention
Group B: Group B: Predicted Non-respondent at LDLPFCActive comparator 1 intervention
Group C: Group C: Predicted Respondent at LDLPFC and LMCActive comparator 1 intervention
Group D: Group D: Predicted Non-respondent at LDLPFC and LMCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity - Mechanical Visual Analogue Scale (M-VAS)
A scale that ranges from 0 to 10 ("No pain" to "Worst possible pain").
Time frame
From baseline to the end of treatment at 16 weeks2
Headache and Pain Log
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.
Time frame
From enrollment to the end of treatment at 16 weeks3
Mood - Hamilton Rating Scale for Depression (HRSD)
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.
Time frame
From baseline to end of treatment at 16 weeks4
Pain Severity - Brief Pain Inventory-Short Form (BPI-sf)
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.
Time frame
Baseline, 1-week, 1-month, 2-monthsSecondary outcomes
1
Opiate/Medication Assessment
This assessment evaluates opiate consumption over the duration of the study. Opioids and narcotics are converted to their morphine equivalent value on a daily basis. Values during each measurement period are added up and divided by the number of weeks to determine weekly usage.
Time frame
From the baseline to the end of treatment at 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Veterans Medical Research Foundation
Lead sponsor
San Diego Veterans Healthcare System
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov