Summary

for people ages 18-65 (full criteria)
healthy people welcome
at UCSD
study started
estimated completion:
Albert Leung (ucsd)

Description

Summary

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

Details

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.

Keywords

Gulf War Syndrome Headache Gulf War Illness Muscle Pain Joint Pain TMS Persian Gulf Syndrome Repetitive transcranial magnetic stimulation Repetitive transcranial magnetic stimulation (sham) Repetitive TMS

Eligibility

For people ages 18-65

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

Locations

  • Naval Medical Center San Diego accepting new patients
    San Diego California 92134 United States
  • Veteran Affairs Hospital accepting new patients
    San Diego California 92161 United States

Lead Scientist

  • Albert Leung (ucsd)
    Clinical Professor, Anesthesiology. Authored (or co-authored) 21 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Veterans Medical Research Foundation
ID
NCT03030794
Study Type
Interventional
Last Updated