Recruiting

rTMS

Sponsor:

Veterans Medical Research Foundation

Code:

NCT04182659

Conditions

Gulf War Syndrome

Gulf War Illness

Headache

Muscle Pain

Joint Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Study Details

Brief summary:

This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.

Conditions

Gulf War Syndrome

Gulf War Illness

Headache

Muscle Pain

Joint Pain

Study ID

NCT04182659

Start date

Oct 1, 2019

Status verified date

Aug, 2023

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Sep 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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
  • Center for Disease Control (CDC) Criteria for Gulf War Illness (GWI)
  • Kansas Criteria for 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active rTMS at the LMC

Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)

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.

Interventions

Transcranial Magnetic Stimulation

A non-invasive treatment that emits magnetic pulses to stimulate the brain.

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 measure

  • Change from baseline to post treatment of GWI-related pain and headaches [ Time Frame: 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 ]
  • Change from baseline to post treatment of headaches [ Time Frame: 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 ]
  • Change from baseline to post treatment of body pain [ Time Frame: 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 ]
  • Change from baseline to post treatment of fibromyalgia [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]
  • Change from baseline to post treatment of neurobehavioral symptoms [ Time Frame: 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. ]
  • Change from baseline to post treatment of sleep quality [ Time Frame: 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 ]
  • Change from baseline to post treatment of fatigue [ Time Frame: Baseline, 1-week, 1-month, 2-month, and 3-month ]

Central Contacts and Locations

Central contacts

Caleb Lopez, BS

858-552-8585caleb.lopez@va.gov

Locations

VA Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Valentino Basilio

650-514-6614Vbasilio@pavir.org

Principal Investigator:

Maheen Adamson, PhD

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Caleb Lopez, BS

858-552-8585caleb.lopez@va.gov

Principal Investigator:

Albert Y Leung, MD

VA Atlanta

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Carly Ragin, BS

404-321-6111Carly.Ragin@va.gov

Principal Investigator:

Anna Woodbury, MD

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Aug 9, 2023

Last verified

Aug, 2023

Keywords

  • rTMS
  • Transcranial Magnetic Stimulation
  • Gulf War Illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2023-08-09.