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Behavioural Intervention
Transcranial Stimulation for Memory Loss (GWI HDtDCS Trial)
N/A
Recruiting
Led By John Hart, Jr, MD
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18 and 50 years old DURING SERVICE in the Gulf War (born between 1940 and 1973)
Be older than 18 years old
Must not have
Non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except English
A history of a neurological disorder, including dementia of any type, moderate to severe traumatic brain injury (TBI), brain tumors, present or past drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Traumatic brain injury will be screened by history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning of hd tdcs/sham treatment, after hdtdcs/sham (2 weeks), at 3 month follow-up and 6 month follow-up
Summary
This trial is testing a non-invasive, non-pharmacological treatment using electric current to stimulate specific brain regions in order to improve word retrieval in Gulf War Illnesses patients.
Who is the study for?
This trial is for US Gulf War veterans who served between 1990-1991, are right-handed, and were aged 18-50 during service. Participants must understand English and be able to consent. Excluded are those with neurological disorders, severe TBI, drug abuse history, certain medication use, pacemakers or metal in the head.
What is being tested?
The study tests High Definition transcranial Direct Current Stimulation (HD tDCS) on brain regions linked to word retrieval in Gulf War Illness patients. It compares active HD tDCS against a sham (inactive) treatment over ten sessions to see if it improves verbal abilities.
What are the potential side effects?
While the investigators expect few side effects from HD tDCS treatment aimed at improving conversational abilities in GWI veterans, potential mild side effects might include discomfort at the stimulation site or temporary headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I served in the Gulf War and was between 18 and 50 years old at that time.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not fluent in English.
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I have a history of serious brain conditions or injuries.
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I don't have a pacemaker, medication pumps, severe heart disease, or non-removable metal near my head.
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I am not taking any medication that affects brain stimulation therapy.
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I am able to understand and agree to the study's procedures and risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ beginning of hd tdcs/sham treatment, after hdtdcs/sham (2 weeks), at 3 month follow-up and 6 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning of hd tdcs/sham treatment, after hdtdcs/sham (2 weeks), at 3 month follow-up and 6 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in performance on the Controlled Oral Word Association Test (COWAT)
Change in the performance on the California Verbal Learning Test (CVLT)
Secondary study objectives
Change in the performance on the Event Related Potential (ERP)
Change in the performance on the Semantic Object Retrieval Test (SORT)
Change in the performance on the Semantic Selection Task
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active HD tDCSActive Control1 Intervention
Administer 10 20-minute sessions of 1 mA anodal High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
Group II: Sham HD tDCSPlacebo Group1 Intervention
Administer 10 20-minute sessions of sham High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
Find a Location
Who is running the clinical trial?
The University of Texas at DallasLead Sponsor
64 Previous Clinical Trials
106,714 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,081 Previous Clinical Trials
1,056,213 Total Patients Enrolled
John Hart, Jr, MDPrincipal InvestigatorThe University of Texas at Dallas
1 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My gender, race, or military rank does not exclude me from this trial.I am fluent in English.I am not fluent in English.I have a history of serious brain conditions or injuries.I don't have a pacemaker, medication pumps, severe heart disease, or non-removable metal near my head.I served in the Gulf War and was between 18 and 50 years old at that time.I am not taking any medication that affects brain stimulation therapy.I am able to understand and agree to the study's procedures and risks.You primarily use your right hand for tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Active HD tDCS
- Group 2: Sham HD tDCS
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.
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