Active rTMS at the LMC for Gulf War Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gulf War Syndrome+4 MoreTranscranial Magnetic Stimulation - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if using magnetic pulses to stimulate the brain can help relieve headaches and pain related to Gulf War Illness.

Eligible Conditions
  • Gulf War Syndrome
  • Muscle Pain
  • Headache
  • Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 3 Secondary · Reporting Duration: Baseline, 1-week, 1-month, 2-month, and 3-month

Baseline and 1-week post treatment
Explore changes in supraspinal resting state functional connectivity
Baseline, 1-week, 1-month, 2-month, and 3-month
Change from baseline to post treatment of GWI-related pain and headaches
Change from baseline to post treatment of PTSD symptoms
Change from baseline to post treatment of body pain
Change from baseline to post treatment of fatigue
Change from baseline to post treatment of fibromyalgia
Change from baseline to post treatment of headaches
Change from baseline to post treatment of muscle pain
Change from baseline to post treatment of quality of life
Change from baseline to post treatment of sensory and affective aspects of pain
Change from baseline to post treatment of sleep difficulties
Change from baseline to post treatment of sleep quality
Change in opioid-based pain medication usage
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 neurobehavioral symptoms

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active rTMS at the LMC
1 of 2
Sham rTMS at the LMC
1 of 2

Active Control

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Active rTMS at the LMC · Has Placebo Group · N/A

Active rTMS at the LMC
Device
ActiveComparator Group · 1 Intervention: Transcranial Magnetic Stimulation · Intervention Types: Device
Sham rTMS at the LMC
Device
ShamComparator Group · 1 Intervention: Sham Transcranial Magnetic Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1-week, 1-month, 2-month, and 3-month

Who is running the clinical trial?

United States Department of DefenseFED
779 Previous Clinical Trials
202,269 Total Patients Enrolled
5 Trials studying Gulf War Syndrome
201 Patients Enrolled for Gulf War Syndrome
Veterans Medical Research FoundationLead Sponsor
40 Previous Clinical Trials
4,427 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
90 Patients Enrolled for Gulf War Syndrome
Albert Leung, M.D.Principal InvestigatorSan Diego Veterans Healthcare System
2 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
90 Patients Enrolled for Gulf War Syndrome

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A person who is male or female and is under the age of 65 can qualify for benefits if they served in the military for at least 30 days consecutively between August 1, 1990 and July 31, 1991 in the Persian Gulf region.
The International Headache Society has developed criteria for diagnosing migraine headaches without aura
An average of the overall daily extremities joint pain intensities for patients was >3 on a 0-10 a NPS.
The patient experiences a headache 3 times a week on average, with an intensity that is greater than 3 on a 0-10 NPS, and the headaches last more than 4 hours.
There are several criteria for GWI, as set by the CDC
The Kansas Criteria for GWI is a set of guidelines used to diagnose and treat Gulf War Syndrome
on the scale The Hamilton Rating Scale of Depression (HRSD) is used to measure the level of depression in individuals
The average muscle pain intensity is more than three on a scale from 0 to 10, using the NPS scale.