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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

Must not have

Inability to give informed consent

History of a psychological or neurological disorder, including dementia of any type, epilepsy or other seizure disorders, post-traumatic stress disorder, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and agree to the study's details.

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I have a history of a serious brain-related health condition.

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I have a defect in my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment differences (active versus sham) in change from baseline to immediately and 2-months post-treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Category Fluency

Rey Auditory Verbal Learning Test and alternative lists

Semantic Object Retrieval Test

+3 more

Secondary study objectives

Digit Span Forward & Backward

Rey-Osterrieth Complex Figure Test

Task-based electroencephalography (EEG) markers during a Go-NoGo task

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met