Active rTMS at the LDLPFC for Gulf War Syndrome

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

Study Summary

This trial will test if rTMS can help relieve symptoms of Gulf War Illness, a condition that causes pain and other co-morbid symptoms.

Eligible Conditions
  • Gulf War Syndrome
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

12 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 depression
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 neurobehavioral symptoms
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

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Active rTMS at the LDLPFC
1 of 4
Active rTMS at the LMC
1 of 4
Sham rTMS at the LDLPFC
1 of 4
Sham rTMS at the LMC
1 of 4

Active Control

Non-Treatment Group

80 Total Participants · 4 Treatment Groups

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

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

VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,742,139 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
128 Patients Enrolled for Gulf War Syndrome
Albert Yick Leung, MDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
2 Previous Clinical Trials
185 Total Patients Enrolled

Eligibility Criteria

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

Mark “Yes” if the following statements are true for you:
You have a score of 14 or higher on the Hamilton Rating Scale of Depression (HRSD).
You are male or female under 65 years of age who served in the Persian Gulf War region for at least 30 consecutive days between August 1, 1990, and July 31, 1991.