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rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)

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ClinicalTrials.gov Identifier: NCT04046536
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.

Condition or disease Intervention/treatment Phase
Gulf War Illness Depression Device: Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation Not Applicable

Detailed Description:
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). Likewise, depression carries a very high co-morbid rate (50%) in patients with chronic pain, and in GWV with GWI related chronic HA and body muscle and joint pain conditions (GWI-HAP). 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 pain and other co-morbid symptoms of GWI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two groups: one will receive active rTMS and the other group will receive sham rTMS.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double-blinded study where only the statistician is aware of the randomization
Primary Purpose: Treatment
Official Title: rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active rTMS at the LDLPFC
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC).
Device: Transcranial Magnetic Stimulation
A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Sham Comparator: Sham rTMS at the LDLPFC
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC.
Device: Sham Transcranial Magnetic Stimulation
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.

Active Comparator: Active rTMS at the LMC
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)
Device: Transcranial Magnetic Stimulation
A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Sham Comparator: Sham rTMS at the LMC
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.
Device: Sham Transcranial Magnetic Stimulation
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.




Primary Outcome Measures :
  1. Change from baseline to post treatment of GWI-related pain and headaches [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  2. Change from baseline to post treatment of sensory and affective aspects of pain [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  3. Change from baseline to post treatment of headaches [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  4. Change from baseline to post treatment of depression [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    The Hamilton Rating Scale for Depression (HRSD) questionnaire will be used to assess depression, which consists of 21 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.

  5. Change from baseline to post treatment of quality of life [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  6. Change from baseline to post treatment of body pain [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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").

  7. Change from baseline to post treatment of muscle pain [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  8. Change from baseline to post treatment of fibromyalgia [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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."

  9. Change from baseline to post treatment of neurobehavioral symptoms [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  10. Change from baseline to post treatment of sleep quality [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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."

  11. Change from baseline to post treatment of sleep difficulties [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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.

  12. Change from baseline to post treatment of fatigue [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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."


Secondary Outcome Measures :
  1. Change from baseline to post treatment of PTSD symptoms [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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

  2. Change in opioid-based pain medication usage [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
    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 VASDHS 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.

  3. Explore changes in supraspinal resting state functional connectivity [ Time Frame: Baseline and 1-week post treatment ]
    The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region
  • CDC Criteria for GWVI (GWI)
  • Kansas Criteria for GWVI (GWI)
  • International Headache Society Criteria for Migraine Headache without aura Average Headache Exacerbation Intensity >3 on 0-10 a Numerical Pain Rating scale (NPS)
  • Average Overall Daily Muscle Pain Intensity >3 on 0-10 a NPS
  • Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 a NPS
  • Headache Exacerbation/attack 3 times per week with the average intensity >3 on a 0-10 NPS, lasting > 4 hours in the past three months
  • Hamilton Rating Scale of Depression (HRSD) 14 based on the sum of scores for the first 17 items

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046536


Contacts
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Contact: Alphonsa Kunnel, BS (858) 552-8585 ext 3146 alphonsa.kunnel@va.gov
Contact: Albert Y Leung, MD (858) 552-8585 ext 3029 Albert.Leung@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Angela Phillips, PhD    650-493-5000 ext 62179    Angela.Phillips4@va.gov   
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Alphonsa Kunnel, BS    (858) 552-8585 ext 3146    alphonsa.kunnel@va.gov   
Principal Investigator: Albert Yick Leung, MD         
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Gabriell Champion, BS    404-321-6111 ext 206277    Gabriell.Champion@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Albert Yick Leung, MD VA San Diego Healthcare System, San Diego, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04046536    
Other Study ID Numbers: SPLD-013-18F
H190020 ( Other Identifier: VASDHS )
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
rTMS
Transcranial Magnetic Stimulation
Gulf War Illness
Depression
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms