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Completed

NCT Number: NCT03030794

Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS

This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.

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Key information

Conditions

Gulf War Syndrome Arthralgia Headache Joint Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Occupational Diseases Pain Pathological Conditions, Signs and Symptoms Persian Gulf Syndrome Signs and Symptoms War-Related Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

A non-invasive method of brain stimulation that emits a magnetic pulse.

Repetitive Transcranial Magnetic Stimulation (Sham)

Device

No brain stimulation will be administered.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Neurobehavioral Symptom Inventory (NSI)

    Time frame: 2 months for each subject (11 visits)

    This is a 22-question self-report assessment that tracks symptoms over time. Each question ranges from 0-4, with 4 being very severe. The total NSI score ranges from 0-88.

  2. Short-Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 2 months for each subject (11 visits)

    This self-reporting survey contains 15 questions that describe the type of pain. Each descriptor is scored between 0-3, with 3 being severe pain. The total score then ranges from 0-45. This questionnaire is filled out one each for joint pain and one for muscle pain.

  3. New Clinical Fibromyalgia Diagnostic Criteria

    Time frame: 2 months for each subject (11 visits)

    This form contains a checklist of 19 possible areas for muscle pain. The checkmarks are tallied to give the Widespread Pain Index score, which ranges from 0-19. A score of 19 would suggest muscle pain in all 19 possible locations.

  4. Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: 2 months for each subject (11 visits)

    This 3-part questionnaire measures the level of interference the pain causes, the overall impact of the pain, and intensity of the symptoms. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always." The FIQR total has a range of 0-210.

  5. Conners Continuous Performance Test 2 (CPT2)

    Time frame: 2 months for each subject (11 visits)

    This is a 15-minute attention task administered on a laptop. The subject is prompted to press the spacebar as quickly as possible after every letter that appears on the screen except for the letter X. The exam is automatically scored by the program and reports omission rate and response latency. The attentional cognitive function is tracked by their change in these scores over time.

  6. Hopkins Verbal Learning Test (HVLT)

    Time frame: 2 months for each subject (11 visits)

    This is a memory and recall task that requires the subject to memorize a list of 10 words and recall them. There are 3 trials and they are scored just by the number of words that can be recalled each time, which can be from 0-10 for a total range of 0-30 words. The second part of this test rates their recognition discrimination index by asking if certain words were on the original list. This is scored by taking the number of true positives and subtracting the false positives. The range for this is from 0-12, with 12 indicative of better discrimination within memory.

  7. Trailmaking Test A&B

    Time frame: 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.

  8. 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.

    Time frame: 2 months for each subject (11 visits)

    This is an administered IQ test that is designed to measure intelligence and cognitive ability in adults and older adolescents. There are several parts to the test, with each response being scored from 0-2 or 0-4 based on the quality of the answer or the completion time. The raw scores are then converted to scaled scores and summed to give the Full Scale score. The higher the Full Scale score, the higher the IQ classification.

  9. Hamilton Rating Scale for Depression

    Time frame: 2 months for each subject (11 visits)

    This questionnaire rates the severity of depression in 21 questions. Each question either ranges from 0-2 or 0-4. The sum of the scores would give the total score, where a higher score would mean more severe depression.

  10. 36-Item Short Form Survey Instrument (SF-36)

    Time frame: 2 months for each subject (11 visits)

    This is a 38-question survey that assesses physical function, physical health limitations, emotional problem limitations, fatigue, emotional well-being, social functioning, pain, and general health. The scoring follows the official guidelines by RAND, where certain questions determine each health aspect. The questions are rated from 1-5, and then scored from 0-100. Each health aspect will have a range of 0-100, with 100 suggesting a more favorable health state.

  11. Sleep Quality Assessment (PSQI)

    Time frame: 2 months for each subject (11 visits)

    This is self-reporting survey has 9 questions and determines the quality and patterns of sleep. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad." The responses will be scored based on the guidelines at the bottom of the page. The global PSQI score then has a range of 0-21, with 21 indicative of poor sleep quality.

  12. Insomnia Severity Index

    Time frame: 2 months for each subject (11 visits)

    This survey has 7 questions that rate the severity of insomnia problems. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28, with 28 being severe clinical insomnia.

  13. Flinders Fatigue Scale

    Time frame: 2 months for each subject (11 visits)

    This questionnaire contains 7 questions in order to determine the level of fatigue one is experiencing. The questions range from 1-5, with 5 being "extremely" or "entirely." The higher one scores, the more severe the fatigue.

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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