Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Daily Headache and Pain Log
Study Overview
Brief Summary
This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.
Detailed Description
Headaches (HA) and wide spread pain are some of the most common debilitating symptoms in Gulf War Veterans (GWV) with Gulf War Illness (GWI). Migraine like HA and diffuse body pain were detected in 64% of GWV with GWI. This high prevalence of chronic HA and diffuse body pain conditions are often associated with neuropsychological dysfunction in mood, attention, memory and other systemic symptoms, which cast a profound negative impact on patients' quality of life. Unfortunately, conventional pharmacological treatments for GWI related headaches and pain (GWI-HAP) has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. Therefore, developing and validating non-invasive and low risk innovative treatment for this patient population is warranted. Transcranial Magnetic Stimulation (TMS) is currently a US FDA approved treatment for major depression and migraine HA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Criteria for veterans with Gulf War Illness headaches and pain:
- •Inclusion Criteria:
- •Male or female between ages 18-65
- •CDC Criteria for GWI
- •Kansas Criteria for GWI
- •International Headache Society Criteria for Migraine HA w/o aura
- •Average Headache Exacerbation Intensity >3 on 0-10 NPRS
- •Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS
- •Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS
- •Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months
Exclusion Criteria
- •Pregnancy
- •History of pacemaker implant
- •Any ferromagnetic (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
- •History of seizure
- •Pending litigation
- •Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
- •Lack of ability to understand the experimental protocol and to adequately communicate in English
- •History of Traumatic Brain injury
- •Chronic Tension or Cluster Headache
- •Ongoing Cognitive Rehabilitation or Treatment of PTSD
- •Criteria for healthy veterans without Gulf War Illness headaches and pain:
- •Inclusion Criteria:
- •Male or female between ages 18-65
- •Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91
- •Exclusion Criteria:
- •CDC Criteria for GWI
- •Kansas Criteria for GWI
- •International Headache Society Criteria for Migraine HA w/o aura
- •Average Headache Exacerbation Intensity >3 on 0-10 NPRS
- •Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS
- •Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS
- •Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months
- •Pregnancy
- •History of pacemaker implant
- •Any ferromagnetic (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
- •History of seizure
- •Pending litigation
- •Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
- •Lack of ability to understand the experimental protocol and to adequately communicate in English
- •History of Traumatic Brain injury
- •Chronic Tension or Cluster Headache
- •Ongoing Cognitive Rehabilitation or Treatment of PTSD
Arms & Interventions
Repetitive TMS
Subjects will receive the repetitive transcranial magnetic stimulation study procedure.
Intervention: Repetitive transcranial magnetic stimulation (Device)
No (blocked) repetitive TMS
Subjects will not receive the repetitive transcranial magnetic stimulation study procedure by blocking the stimulation between the coil and the head, but the audiovisual conditions will be mimicked.
Intervention: Repetitive transcranial magnetic stimulation (sham) (Device)
Outcomes
Primary Outcomes
Daily Headache and Pain Log
Time Frame: 2 months for each subject (11 visits)
This is a daily self-reporting log that tracks headache, muscle pain, and joint pain levels. The pain levels are scored from 0-10 with 10 being the worst possible pain.
Opioid Medication Assessment
Time Frame: 2 months for each subject (11 visits)
This is a self-reporting log that tracks opioid medication usage. Average daily dosages are converted to equal-potent oral Morphine Sulfate dosage and reported in milligrams.
Headache Impact Test 6 (HIT-6)
Time Frame: 2 months for each subject (11 visits)
This 6-question form assesses the severity of headache pain and is scored with a range of 36-78. The higher score, the higher the impact of headaches on functional ability.
2 months for each subject (11 visits)
Time Frame: 2 months for each subject (11 visits)
This assessment has 9 questions about pain level, relief, and interference. Pain level and interference questions range from 0-10, with 10 being the worst. Level of relief has a range of 0-100%, with 100% being complete relief.
Mechanical-Visual Analogue Scale
Time Frame: 2 months for each subject (11 visits)
This scale measures the level of headache, muscle, and joint pain at each visit. This ranges from 0-100, with 100 being the worst possible pain.
Secondary Outcomes
- Neurobehavioral Symptom Inventory (NSI)(2 months for each subject (11 visits))
- Short-Form McGill Pain Questionnaire (SF-MPQ)(2 months for each subject (11 visits))
- Hopkins Verbal Learning Test (HVLT)(2 months for each subject (11 visits))
- This is a timed test that is administered to assess executive function. Both tests have a series of numbers or numbers and letters that are to be connected in sequential order. The faster the completion time, the better the executive function.(2 months for each subject (11 visits))
- Hamilton Rating Scale for Depression(2 months for each subject (11 visits))
- 36-Item Short Form Survey Instrument (SF-36)(2 months for each subject (11 visits))
- Sleep Quality Assessment (PSQI)(2 months for each subject (11 visits))
- New Clinical Fibromyalgia Diagnostic Criteria(2 months for each subject (11 visits))
- Conners Continuous Performance Test 2 (CPT2)(2 months for each subject (11 visits))
- Revised Fibromyalgia Impact Questionnaire (FIQR)(2 months for each subject (11 visits))
- Trailmaking Test A&B(2 months for each subject (11 visits))
- Insomnia Severity Index(2 months for each subject (11 visits))
- Flinders Fatigue Scale(2 months for each subject (11 visits))