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Non-invasive Brain Stimulation

rTMS for Gulf War Syndrome

N/A
Recruiting
Led By Albert Yick Leung, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Headache Exacerbation/attack once a week with the average intensity >3 on a 0-10 NPS, lasting > 1 hour in the past three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week, 1-month, 2-month, and 3-month
Awards & highlights

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.

Who is the study for?
This trial is for Gulf War veterans under 65 who experience weekly headaches, muscle and joint pain, meet specific GWI criteria, and have a certain level of depression. It's not for those with pacemakers, metal in their body that affects MRI scans, major psychiatric conditions, other chronic pain states, history of seizures or brain injury.Check my eligibility
What is being tested?
The study tests if repetitive transcranial magnetic stimulation (rTMS) can reduce pain and related symptoms in Gulf War Illness. Participants will receive either real rTMS or a sham (fake) treatment to compare effectiveness.See study design
What are the potential side effects?
rTMS may cause discomfort at the site of application on the scalp, headache during or after treatment, lightheadedness, tingling or spasms of facial muscles. Rarely it could induce seizures but is generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 65 and served in the Persian Gulf War region for at least 30 days.
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I experience severe headaches weekly that last more than an hour.
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My daily muscle pain is more than 3 on a scale of 0 to 10.
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My daily joint pain in my arms or legs averages more than 3 out of 10.
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My daily muscle pain is more than 3 on a scale of 0 to 10.
Select...
I am under 65 and served in the Persian Gulf War region for at least 30 days.
Select...
My daily joint pain in my arms or legs averages more than 3 out of 10.
Select...
I experience severe headaches weekly that last more than an hour.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week, 1-month, 2-month, and 3-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week, 1-month, 2-month, and 3-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to post treatment of GWI-related pain and headaches
Change from baseline to post treatment of body pain
Change from baseline to post treatment of depression
+9 more
Secondary outcome measures
Change from baseline to post treatment of PTSD symptoms
Change in opioid-based pain medication usage
Explore changes in supraspinal resting state functional connectivity

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Active rTMS at the LDLPFCActive Control1 Intervention
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC).
Group II: Active rTMS at the LMCActive Control1 Intervention
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)
Group III: Sham rTMS at the LDLPFCPlacebo Group1 Intervention
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC.
Group IV: Sham rTMS at the LMCPlacebo Group1 Intervention
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,925 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
236 Total Patients Enrolled

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04046536 — N/A
Gulf War Syndrome Research Study Groups: Active rTMS at the LDLPFC, Sham rTMS at the LDLPFC, Active rTMS at the LMC, Sham rTMS at the LMC
Gulf War Syndrome Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT04046536 — N/A
rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046536 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to be involved in this research experiment?

"This trial is currently seeking 80 individuals suffering from depression aged between 18 and 65. To qualify, participants must experience recurrent headaches of over 3/10 intensity on a Numerical Pain Rating scale (NPS) lasting more than 4 hours in the preceding three months, be judged as having Migraine headache without aura according to International Headache Society Criteria scoring 14 or above on the Hamilton Rating Scale of Depression (HRSD), report average daily muscle pain intensity and joint pain at greater-than-3 levels on an NPS 0-10 rating system, and have served for 30 consecutive days in the Persian Gulf War region between August"

Answered by AI

Are participants aged 55 and over being sought out for this research?

"This clinical trial mandates that patients must be aged 18 or above, but cannot exceed the age of 65."

Answered by AI

What is the current tally of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this health trial is in the process of enlisting participants and was initially uploaded on October 1st 2019; subsequently updated February 4th 2022. The research project seeks 80 individuals across 3 medical facilities."

Answered by AI

Is it possible to register for this clinical trial at present?

"Affirmative. According to clinicaltrials.gov, this medical research is currently enrolling participants which started on October 1st 2019 and has since been revised on February 4th 2022. Presently the trial requires 80 patients that will be sourced from three different sites."

Answered by AI
~20 spots leftby Sep 2025