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

August 8, 2023 updated by: VA Office of Research and Development

rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • Recruiting
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Contact:
      • San Diego, California, United States, 92161-0002
        • Recruiting
        • VA San Diego Healthcare System, San Diego, CA
        • Principal Investigator:
          • Albert Yick Leung, MD
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical and Rehab Center, Decatur, GA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 once a week with the average intensity >3 on a 0-10 NPS, lasting > 1 hour in the past three months
  • Hamilton Rating Scale of Depression (HRSD) greater than or equal to 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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").
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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."
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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."
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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."
Baseline, 1-week, 1-month, 2-month, and 3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline, 1-week, 1-month, 2-month, and 3-month
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.
Baseline and 1-week post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Albert Yick Leung, MD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLD-013-18F
  • H190020 (Other Identifier: VASDHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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