Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
- Conditions
- Traumatic Brain InjuryWord Finding DifficultyAcquired Brain InjuryCognitive Change
- Interventions
- Device: Active Transcranial direct current stimulationDevice: Sham Transcranial direct current stimulation
- Registration Number
- NCT05408975
- Lead Sponsor
- The University of Texas at Dallas
- Brief Summary
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-veteran) participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition, concussion history, structural brain imaging, and EEG predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
- Detailed Description
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with remote traumatic brain injury by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at 2-months follow-up testing sessions.
Civilians with histories of traumatic brain injuries and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline). Magnetic resonance imaging of the brain will be obtained only at the baseline assessment.
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and one time following treatment competition (i.e., 2-months). For participants who complete the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment session 10 and one time following competition of the second treatment (i.e., 2-months).
This study was funded by NIH/NIDCD under grant number \[1K99DC020185\]. Federal funding concluded on 11/30/2024.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Participants are to be between the ages of 18-85, are non-military personnel and not veterans, and 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. Traumatic brain injury must be in the mild to moderate range based on evaluation, including the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.
- an implanted/electronic device, such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.).
- skull defects
- a 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.
- inability to give informed consent
- currently pregnant
- not a native English speaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active to Sham Transcranial direct current stimulation Sham Transcranial direct current stimulation 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. Active to Sham Transcranial direct current stimulation Active Transcranial direct current stimulation 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. Sham to Active transcranial direct current stimulation Active Transcranial direct current stimulation 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. Sham to Active transcranial direct current stimulation Sham Transcranial direct current stimulation 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.
- Primary Outcome Measures
Name Time Method The Controlled Oral Word Association Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Number of Correct Items Generated
Category Fluency Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated
Rey Auditory Verbal Learning Test and alternative lists Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.
The Boston Naming Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.
Semantic Object Retrieval Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Number of Correct Retrievals.
The Delis Kaplan Color Word Interference Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
- Secondary Outcome Measures
Name Time Method The Trail Making Test (Parts A & B) Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution
Digit Span Forward & Backward Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span
The Digit Symbol Substitution Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items
Task-based electroencephalography (EEG) markers during a Go-NoGo task Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes.
Rey-Osterrieth Complex Figure Test Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score
Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.
Trial Locations
- Locations (2)
The University of Texas at Dallas
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States