Clinical trial NCT05408975: Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)
Official title: Treatment of Word Finding Difficulties and Verbal Retrieval Deficits in Civilians Who Sustain a Chronic Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Word Finding Difficulty
Acquired Brain Injury
Cognitive Change
Keywords: transcranial direct current stimulation
electroencephalography
Cognition
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-06-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to 1 of 2 treatment arms: (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, all participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be and re-evaluated at 2-months follow-up testing sessions.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Controlled Oral Word Association Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Category Fluency
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: The Boston Naming Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Semantic Object Retrieval Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: The Delis Kaplan Color Word Interference Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Rey Auditory Verbal Learning Test and alternative lists
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Secondary outcomes:
measure: The Trail Making Test (Parts A & B)
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Digit Span Forward & Backward
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Rey-Osterrieth Complex Figure Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: The Digit Symbol Substitution Test
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Task-based electroencephalography (EEG) markers during a Go-NoGo task
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
measure: Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task
timeFrame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas at Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: John Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adhikari. A., Devora, P., Vintila, T., Mathews, A., Nguyen, B., Motes, M., LoBue, C., Cullum, C.M., Hart, J., Chiang, H.-S., B - 36 Investigating High-Definition Transcranial Direct Current Stimulation for Remediating Word Finding Difficulty in Civilians with a History of Chronic Traumatic Brain Injury: a Pilot Study, Archives of Clinical Neuropsychology, Volume 39, Issue 7, October 2024, Page 1126