Treating Word Finding Difficulties in Traumatic Brain Injury With HD-tDCS

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury; Cognitive Change; Word Finding Difficulty; Acquired Brain Injury

• Registration Number: NCT06840808
• 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).

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).

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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, including both letter and category fluency. Metric: Number of Correct Items Generated
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.
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 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
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 0 to 36, the higher the better
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
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
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.
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 (1)

The University of Texas at Dallas; 🇺🇸 Richardson, Texas, United States