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Behavioural Intervention

HD-tDCS for Traumatic Brain Injury

Phase 1 & 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 are to be between the ages of 18-85
Participants must have had a traumatic brain injury (more than a year ago prior to study participation) that has led to a complaint of word finding difficulty since the brain injury, confirmed to represent a verbal retrieval deficit based on neuropsychological testing criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment differences (active versus sham) in change from baseline to immediately and 2-months post-treatment.
Awards & highlights

Study Summary

This trial is testing whether electrical stimulation of the brain can improve verbal retrieval in people with histories of traumatic brain injuries.

Who is the study for?
This trial is for civilian adults aged 18-85 who have had a mild to moderate traumatic brain injury over a year ago and are experiencing word finding difficulties. They must be fluent in English, without implanted devices, major psychological or neurological disorders, current drug abuse, pregnancy, or skull defects.Check my eligibility
What is being tested?
The study tests if low-level electric brain stimulation (tDCS) on the pre-supplementary motor area improves verbal retrieval in people with traumatic brain injuries. It involves comparing active tDCS with sham (placebo) treatment using neuropsychological assessments and EEG measures.See study design
What are the potential side effects?
Potential side effects of transcranial direct current stimulation may include discomfort at the electrode site, itching, tingling sensation during application, headache, fatigue and nausea. However these are generally mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I've had a brain injury over a year ago and struggle with finding words.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment differences (active versus sham) in change from baseline to immediately and 2-months post-treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment differences (active versus sham) in change from baseline to immediately and 2-months post-treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Category Fluency
Rey Auditory Verbal Learning Test and alternative lists
Semantic Object Retrieval Test
+3 more
Secondary outcome measures
Digit Span Forward & Backward
Rey-Osterrieth Complex Figure Test
Task-based electroencephalography (EEG) markers during a Go-NoGo task
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham to Active transcranial direct current stimulationExperimental Treatment2 Interventions
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
Group II: Active to Sham Transcranial direct current stimulationExperimental Treatment2 Interventions
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Transcranial direct current stimulation
2014
N/A
~190

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,441 Total Patients Enrolled
The University of Texas at DallasLead Sponsor
58 Previous Clinical Trials
106,245 Total Patients Enrolled
John Hart, MDPrincipal InvestigatorUniversity of Texas at Dallas
2 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

Transcranial direct current stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05408975 — Phase 1 & 2
Traumatic Brain Injury Research Study Groups: Sham to Active transcranial direct current stimulation, Active to Sham Transcranial direct current stimulation
Traumatic Brain Injury Clinical Trial 2023: Transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT05408975 — Phase 1 & 2
Transcranial direct current stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408975 — Phase 1 & 2

Frequently Asked Questions

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

Is this examination limited to those under 70 years of age?

"This medical research project is open to individuals aged 18 or above, and below 75."

Answered by AI

Are there any spots remaining for this research opportunity?

"Affirmative. Clinicaltrials.gov data attest to the fact that this trial, which was initially published on August 1st 2022, is currently in need of recruits. Approximately 30 patients must be sourced from a single medical centre."

Answered by AI

What is the intended outcome of this clinical investigation?

"The primary objective of this study is to observe the differences in results between active and sham treatments on The Controlled Oral Word Association Test. Secondary outcomes include evaluation of Digit Symbol Substitution, EEG markers during a Go-NoGo task with varying levels of complexity, as well as changes to Memory Span scores based on the Wechsler Adult Intelligence Scale (WAIS-IV). Changes will be monitored over two months following treatment initiation."

Answered by AI

Am I eligible to participate in this experiment?

"This clinical trial seeks 30 human test subjects with a history of mild-to-moderate traumatic brain injury (TBI) and aged 18 to 75. To be eligible, they must not have served in the military nor be veterans, as well as demonstrate word finding difficulty since their TBI was diagnosed. Furthermore, candidates need to possess proficient reading and speaking English skills which will be assessed via the Ohio State TBI Identification Method."

Answered by AI

How many individuals have enlisted in this research endeavor?

"That's correct. Online records hosted on clinicaltrials.gov show that this medical trial, which was launched on August 1st 2022, is still actively searching for participants. 30 people are needed from a single site to complete the study."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas at Dallas
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
John Hart, Jr. 2023. "Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408975.
All > Aphasia > Tdcs
~9 spots leftby Dec 2024
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