This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.
Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating headaches, muscle, and joint pain symptoms of GWI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
A non-invasive treatment that emits magnetic pulses to stimulate the brain.
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.
VA Palo Alto
Palo Alto, California, United States
RECRUITINGVA San Diego Healthcare System
San Diego, California, United States
RECRUITINGVA Atlanta
Decatur, Georgia, United States
RECRUITINGChange from baseline to post treatment of GWI-related pain and headaches
This outcome will be measured through daily self-reporting logs that tracks headache, muscle, and joint pain. A numerical rating scale of 0, being no pain, to 10, being worst possible pain, will be used to report pain and headaches.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of sensory and affective aspects of pain
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 and joint pain.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of headaches
The Headache Impact Test (HIT-6) will be used to measure how headaches affect the individual's ability to function in different domains. This 6-question form assesses the severity of headache pain and is scored with a range of 36-78, with higher scores indicating a larger impact of headaches on functionality.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of quality of life
The Short Form Health Survey-36 (SF-36) is a self-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.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of body pain
A Brief Pain Inventory-Short Form (BPI-SF) questionnaire will also be used to assess the severity of pain and the impact of pain on daily functions. 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").
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Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of muscle pain
The New Clinical Fibromyalgia Diagnostic Criteria - Part 1 will be used to assess muscle pain. Patients will be asked to rate the average (over the past 24 hours) intensity of muscle pain for up to 12 locations of the body.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of fibromyalgia
A Revised Fibromyalgia Impact Questionnaire will be used to evaluate the function, overall impact and symptoms of Fibromyalgia. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always."
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of neurobehavioral symptoms
Baseline, 1-week, 1-month, 2-month, and 3-month
Time frame: The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
Change from baseline to post treatment of sleep quality
The Pittsburgh Sleep Quality Index (PSQI) questionnaire has nineteen individual items which are used to generate seven composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad."
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of sleep difficulties
The Insomnia Severity Index measures the severity of an individual's sleep difficulties. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of fatigue
The Flinders Fatigue Scale measures daytime fatigue associated with insomnia through a 7-item questionnaire. The questions range from 1-5, with 5 being "extremely" or "entirely."
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of PTSD symptoms
The Clinician-Administered PTSD Scale (CAPS-5), 30-item structured interview that can be used to diagnose PTSD and associated symptoms, will be used to assess PTSD symptoms
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Change in opioid-based pain medication usage
Medication assessment consists of daily chronic and breakthrough opioid usage for pain or headache. Average daily dosage will be converted to equal-potent oral Morphine Sulfate dosage based on the clinical opioid conversion table used by the VA San Diego Healthcare System Pain Service and University of California, San Diego, Center for Pain Medicine. The study participants will be asked to remain on the same analgesic medication(s) during the study period but are allowed to titrate down their narcotic usage.
Time frame: Baseline, 1-week, 1-month, 2-month, and 3-month
Explore changes in supraspinal resting state functional connectivity
The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing.
Time frame: Baseline and 1-week post treatment