Clinical trial NCT06840808: Treating Word Finding Difficulties in Traumatic Brain Injury With HD-tDCS
Official title: Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (HDtDCS-CTBI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Change
Word Finding Difficulty
Acquired Brain Injury
Keywords: electroencephalography
transcranial direct current stimulation
Cognition
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2025-02-21
Enrollment: 10
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).

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).

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-85
* Traumatic brain injury more than a year prior to study participation
* Word finding difficulty since the brain injury
* Fluent in speaking and reading English.

Exclusion Criteria:

* 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
* 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
* Military personnel or Veteran
* Currently pregnant
* Not fluent 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: The Boston Naming 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.
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.
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: Richardson
country: United States
facility: The University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: John Hart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motes MA, Spence JS, Yeatman K, Jones PM, Lutrell M, O'Hair R, Shakal S, DeLaRosa BL, To W, Vanneste S, Kraut MA, Hart J , Jr. High-Definition Transcranial Direct Current Stimulation to Improve Verbal Retrieval Deficits in Chronic Traumatic Brain Injury. J Neurotrauma. 2020 Jan 1;37(1):170-177. doi: 10.1089/neu.2018.6331. Epub 2019 Sep 3.
citation: Chiang HS, Motes M, O'Hair R, Vanneste S, Kraut M, Hart J Jr. Baseline delayed verbal recall predicts response to high definition transcranial direct current stimulation targeting the superior medial frontal cortex. Neurosci Lett. 2021 Nov 1;764:136204. doi: 10.1016/j.neulet.2021.136204. Epub 2021 Sep 1.
citation: Chiang HS, Motes M, Kraut M, Vanneste S, Hart J. High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. Clin Neurophysiol. 2022 Nov;143:36-47. doi: 10.1016/j.clinph.2022.08.015. Epub 2022 Aug 30.