Summary

for people ages 18-65 (full criteria)
at San Diego, California
study started
estimated completion
Albert Yick Leung, MD

Description

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.

Official Title

rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI

Details

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.

Keywords

Gulf War Illness Depression rTMS Transcranial Magnetic Stimulation

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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

Location

  • VA San Diego Healthcare System, San Diego, CA accepting new patients
    San Diego California 92161 United States

Lead Scientist

  • Albert Yick Leung, MD
    Clinical Professor, Anesthesiology. Authored (or co-authored) 22 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04046536
Study Type
Interventional
Last Updated