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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
Headache Exacerbation/attack once a week with the average intensity >3 on a 0-10 NPS, lasting > 1 hour in the past three months
Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 a NPS
Must not have
Chronic Tension or Cluster Headache
Lack of ability to understand the experimental protocol and to adequately communicate in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week, 1-month, 2-month, and 3-month
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.
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.
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 belowSelect...
I experience severe headaches weekly that last more than an hour.
Select...
My daily joint pain in my arms or legs averages more than 3 out of 10.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I suffer from chronic tension or cluster headaches.
Select...
I understand the study and can communicate in English.
Select...
I have low back pain due to a nerve or joint problem.
Select...
I do not have a history of dementia, major psychiatric diseases, or life-threatening diseases.
Select...
I have chronic nerve pain like CRPS or painful neuropathy.
Select...
I have had seizures in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-week, 1-month, 2-month, and 3-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week, 1-month, 2-month, and 3-month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,729 Total Patients Enrolled
78 Trials studying Depression
19,898 Patients Enrolled for Depression
Albert Yick Leung, MDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
2 Previous Clinical Trials
236 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving therapy for my memory/thinking or PTSD.I suffer from chronic tension or cluster headaches.I experience severe headaches weekly that last more than an hour.My daily joint pain in my arms or legs averages more than 3 out of 10.I understand the study and can communicate in English.I have low back pain due to a nerve or joint problem.My daily muscle pain is more than 3 on a scale of 0 to 10.I am under 65 and served in the Persian Gulf War region for at least 30 days.I do not have a history of dementia, major psychiatric diseases, or life-threatening diseases.I have chronic nerve pain like CRPS or painful neuropathy.I have had seizures in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS at the LDLPFC
- Group 2: Sham rTMS at the LDLPFC
- Group 3: Active rTMS at the LMC
- Group 4: Sham rTMS at the LMC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.