Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-TX240370 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs (CDMRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Diego Veterans Healthcare System | FED |
| Congressionally Directed Medical Research Programs | FED |
Not provided
Not provided
Not provided
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:
Participants will undergo the following:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Repetitive Transcranial Magnetic Stimulation | Device | rTMS will be administered to the LDLPFC with an active coil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity - Mechanical Visual Analogue Scale (M-VAS) | A scale that ranges from 0 to 10 ("No pain" to "Worst possible pain"). | From baseline to the end of treatment at 16 weeks |
| 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. | From enrollment to the end of treatment at 16 weeks |
| 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. | From baseline to end of treatment at 16 weeks |
| 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. | Baseline, 1-week, 1-month, 2-months |
| 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 9A-9G are summed together for a total pain interference score. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the baseline to the end of treatment at 16 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albert Y Leung, MD | Contact | 8585528585 | 3866 | ayleung@health.ucsd.edu |
| Caleb Lopez, BS | Contact | 8585528585 | 2638 | caleb.lopez@va.gov |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jennifer Moreno Department of Veterans Affairs Medical Center | Recruiting | San Diego | California | 92161 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Repetitive Transcranial Magnetic Stimulation | Device | rTMS will be administered to the LDLPFC with an active coil. |
|
| Active Repetitive Transcranial Magnetic Stimulation | Device | rTMS will be administered to the LDLPFC and LMC with an active coil. |
|
| Active Repetitive Transcranial Magnetic Stimulation | Device | rTMS will be administered to the LDLPFC and LMC with an active coil. |
|
| Baseline, 1-week, 1-month, 2-months |
| Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ) | This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle pain. The SF-MPQ consists of fifteen questions; items 1-11 are measured on a 4-point response scale ranging from 0 to 3 ("None" to "Severe"). Items 12-15 include a visual analogue scale (VAS) from "No pain" to "Worst possible pain" and Present Pain Intensity (PPI) ranging from 0 to 5 ("No pain" to "Excruciating") ranking overall pain intensity for a total average muscle pain score. This is calculated via the average VAS scores (0-100) with 0 indicating no pain and 100 equivalent to the worst pain possible. | Baseline, 1-week, 1-month, 2-months |
| Pain Quality and Intensity - Short Form McGill Pain Questionnaire (SF-MPQ) | This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of joint pain. The SF-MPQ consists of fifteen questions; items 1-11 are measured on a 4-point response scale ranging from 0 to 3 ("None" to "Severe"). Items 12-15 include a visual analogue scale (VAS) from "No pain" to "Worst possible pain" and Present Pain Intensity (PPI) ranging from 0 to 5 ("No pain" to "Excruciating") ranking overall pain intensity for a total average joint pain score. This is calculated via the average VAS scores (0-100) with 0 indicating no pain and 100 equivalent to the worst pain possible. | Baseline, 1-week, 1-month, 2-months |
| Functionality - Revised Fibromyalgia Impact Questionnaire | A questionnaire to evaluate the function, overall impact and symptoms of Fibromyalgia. The 3 categories are calculated by the sum of the scores to produce a total score. Each item ranges from 0-10 and the total score is 0-100 with high scores indicating more severe impact. | Baseline, 1-week, 1-month, 2-months |
| Pain Intensity - New Clinical Fibromyalgia Diagnostic Criteria - Part 1 | Patients will be asked to rate the average (over the past week) intensity of muscle pain up to 12 locations of the body. This is calculated by the Widespread Pain Index (WPI) total score ranging from 0 to 19 and a marker visual analogue scale (MVAS) ranging from 0 to 100. | Baseline, 1-week, 1-month, 2-months |
| Pain Severity - Headache Impact Test (HIT-6) | This test measures how impact headaches affect the individual's ability to function in different domains. This six question test evaluates the severity of headache pain from "Never" to "Always" with a total range between 36-78, higher scores indicating greater impact on functionality. | Baseline, 1-week, 1-month, 2-months |
| Pain Severity - Neurobehavioral Symptoms Inventory (NSI) | This twenty-two self-report questionnaire on the severity of each symptom is measured using a 5-point response scale ranging from 0 to 4 ("None - Rarely if ever present; not a problem at all" to "Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help"). It asks the subjects to indicate the extent to which each symptom has disturbed them. The total score ranges from 0 to 88 with a higher score indicating very severe symptom disruption. | Baseline, 1-week, 1-month, 2-months |
| Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) | This index has nineteen individual items which are used to generate 7 composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 7 components measure sleep habits and sum together to measure global sleep quality with a high score of 0-21 with a higher score indicating worse sleep quality. | Baseline, 1-week, 1-month, 2-months |
| Sleep Severity - Insomnia Severity Index | This index consists of seven questions that depict the severity of sleep difficulties within the past 2 weeks on a 5-point response scale that rates satisfaction, noticeability, distress, and interference with daily functioning. A score between 15 and 21 suggests moderately severe clinical insomnia. A score of 22 or greater represents severe clinical insomnia. | Baseline, 1-week, 1-month, 2-months |
| Quality of Life - Veteran RAND 36-item Health Survey (VR-36+PCS and MCS) | A patient-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health. | Baseline, 1-week, 1-month, 2-months |
| Multidimensional Fatigue Inventory | A twenty item self-report instrument with 4 categories total designed to measure fatigue level (24-96) with a higher score indicating more severe fatigue. | Baseline, 1-week, 1-month, 2-months |
| Chronic Fatigue Severity Scale | A Likert scale consisting of nine items that assess fatigue severity and functionality. The sum of all questions provides total fatigue level 8-63 with a higher score being more severe. A score over 36 indicates patient may be suffering from fatigue. | Baseline, 1-week, 1-month, 2-months |
| ID | Term |
|---|---|
| D006261 | Headache |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided