Treating Civilian Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (ciTBI-HDtDCS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Traumatic Brain Injury; Acquired Brain Injury; Word Finding Difficulty
• Intervention / Treatment: Device: Active Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75235
      • The University of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active to 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.	Device: Active Transcranial direct current stimulation; Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.; Other Names: tDCS; 1 milliamp tDCS; High definition tDCS; High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10; Device: Sham Transcranial direct current stimulation; Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
Experimental: Sham to 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.	Device: Active Transcranial direct current stimulation; Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.; Other Names: tDCS; 1 milliamp tDCS; High definition tDCS; High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10; Device: Sham Transcranial direct current stimulation; Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Controlled Oral Word Association Test	Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Category Fluency	Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Boston Naming Test	Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Semantic Object Retrieval Test	Evaluation of treatment differences (active versus sham) in change in Semantic Object Retrieval Test. Metric: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Delis Kaplan Color Word Interference Test, Naming	Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Delis Kaplan Color Word Interference Test, Reading	Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Delis Kaplan Color Word Interference Test, Inhibition	Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Delis Kaplan Color Word Interference Test, Inhibition and Switching	Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning	Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall	Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Trail Making Test - Part A	Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Trail Making Test - Part B	Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A&B). Metric: Time to Solution. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Digit Span Forward	Evaluation of treatment differences (active versus sham) in change in Digit Span Forward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a forward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Digit Span Backward	Evaluation of treatment differences (active versus sham) in change in Digit Span Backward. Metric: Memory Span, a composite score of how many numbers are repeated correctly in a backward order. Z = 0 is the normed average, with positive Z values better and negative Z values worse than the normed average.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Rey-Osterrieth Complex Figure Test - Delayed Recall	Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score. Total Range 0 (minimum) - 36 (maximum). This is a summed score of the number and accuracy of complex figure features captured. Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
The Digit Symbol Substitution Test	Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.	Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas
• Collaborators: National Institutes of Health (NIH); National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: John Hart, MD, University of Texas at Dallas

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; Cognition; electroencephalography
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Brain Injuries; Anomia; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 23-231 (Other Identifier: The UNIVERSITY OF TEXAS AT DALLAS); 1K99DC020185-01A1 (U.S. NIH Grant/Contract); 5K99DC020185-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will share data upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No