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Behavioural Intervention
Transcranial Direct Current Stimulation for Mild Traumatic Brain Injury (HDtDCS-TBI Trial)
Phase 2
Recruiting
Led By John Hart, 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
Participants must have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria
Participants must be between the ages of 18-75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment
Awards & highlights
HDtDCS-TBI Trial Summary
This trial is testing whether stimulating the brain with low levels of electricity can help improve verbal memory in military veterans with a history of concussion.
Who is the study for?
This trial is for US military veterans aged 18-75 with mild to moderate traumatic brain injury that has affected their verbal skills. They must be fluent in English and have no severe neurological disorders, drug abuse history, or conditions affecting the brain's blood vessels. Participants taking certain medications or with cranial implants cannot join.Check my eligibility
What is being tested?
The study tests if a low-level electric brain stimulation technique called transcranial Direct Current Stimulation (tDCS) can improve memory-related verbal skills in participants with traumatic brain injuries. It compares real tDCS to sham (fake) treatment using neuropsychological assessments and EEG measures.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, nausea. More serious risks are rare but could involve seizures or mood changes.
HDtDCS-TBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have difficulty finding words due to a brain injury.
Select...
I am between 18 and 75 years old.
HDtDCS-TBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measures will be assessed as change over a period of 17 weeks: change from baseline to 3-month post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
+7 moreSecondary outcome measures
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
+13 moreHDtDCS-TBI Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial direct current stimulationExperimental Treatment1 Intervention
20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions
Group II: Sham transcranial direct current stimulationPlacebo Group1 Intervention
20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial direct current stimulation
2012
Completed Phase 3
~650
Find a Location
Who is running the clinical trial?
The University of Texas at DallasLead Sponsor
58 Previous Clinical Trials
106,155 Total Patients Enrolled
John Hart, MDPrincipal InvestigatorUniversity of Texas at Dallas
2 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty finding words due to a brain injury.I have implants or defects in my skull that could interfere with brain stimulation treatments.My brain injury is considered mild to moderate.I am not taking any medication that could affect tDCS treatment.I have a history of serious brain-related health issues or substance abuse.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Transcranial direct current stimulation
- Group 2: Sham transcranial direct current stimulation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are minors included in the patient pool for this research project?
"From the eligibility requirements, it appears that the lower age limit for this study is 18 and the upper bound is 75."
Answered by AI
Could you please list any potential dangers of Transcranial direct current stimulation?
"Transcranial direct current stimulation is estimated to be a 2 in terms of safety. This rating comes from the fact that, while Phase 2 trials have some data supporting safety, there is no evidence at this time indicating that the intervention is effective."
Answered by AI
How many test subjects are enrolled in this experiment?
"The correct. The clinicaltrial.gov website has the most recent information regarding this trial, which is still recruiting patients. This particular trial was posted on 8/1/2021 and updated on 9/14/2022. They are currently looking for 80 people to participate at 1 location."
Answered by AI
Are there any unfilled positions in this clinical trial for new patients?
"Yes, the trial is currently open and looking for patients. Based on the information available on clinicaltrials.gov, the study was originally posted on August 1st, 2021 and was last edited on September 14th, 2022. 80 people will be enrolled from 1 site."
Answered by AI
Who does this research include in its participant pool?
"This ongoing clinical trial is testing a new intervention for patients that have suffered from traumatic brain injury (TBI). To be eligible, participants must be between 18 and 75 years old. So far, 80 people have been enrolled in the study."
Answered by AI
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