Skip to main content
OpenTrials
Completed

NCT Number: NCT05408975

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Acquired Brain Injury Anomia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognitive Change Communication Disorders Craniocerebral Trauma Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Word Finding Difficulty Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Dallas, Dallas, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

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

Sham Transcranial Direct Current Stimulation

Device

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.

Primary outcomes

  1. The Controlled Oral Word Association Test

    Time frame: 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: Total Number of Correct Items Generated for three different letters. Total Range 0 (minimum) - 200 (maximum). Larger numbers indicate better performance.

  2. Category Fluency

    Time frame: 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: Total Number of Correct Items Generated for Animal. Total Range 0 (minimum) - 100 (maximum). Larger numbers indicate better performance.

  3. The Boston Naming Test

    Time frame: 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 - 30 items. Metric: Total Number of Correct Items Generated. Total Range 0 (minimum) - 30 (maximum). Larger numbers indicate better performance.

  4. Semantic Object Retrieval Test

    Time frame: 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: Total Number of Correct Retrievals. Total Range 0 (minimum) - 32 (maximum). Larger numbers indicate better performance.

  5. The Delis Kaplan Color Word Interference Test, Naming

    Time frame: 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 - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.

  6. The Delis Kaplan Color Word Interference Test, Reading

    Time frame: 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 - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.

  7. The Delis Kaplan Color Word Interference Test, Inhibition

    Time frame: 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 - seconds to Name Items. Total Range 0 (minimum) - 150 (maximum). Longer time indicates worse performance.

  8. The Delis Kaplan Color Word Interference Test, Inhibition and Switching

    Time frame: 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 - seconds to Name Items. Total Range 0 (minimum) - 240 (maximum). Longer time indicates worse performance.

  9. Rey Auditory Verbal Learning Test and Alternative Lists, Total Learning

    Time frame: 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. Total Range 0 (minimum) - 75 (maximum). Larger numbers indicate better performance.

  10. Rey Auditory Verbal Learning Test and Alternative Lists, Delayed Recall

    Time frame: 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: Total Number of Delayed Recall items and Correct Recalls. Total Range 0 (minimum) - 15 (maximum). Larger numbers indicate better performance.

Secondary outcomes

  1. The Trail Making Test - Part A

    Time frame: 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. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.

  2. The Trail Making Test - Part B

    Time frame: 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. Total Range 0 (minimum) - 300 (maximum). Longer time indicates worse performance.

  3. Digit Span Forward

    Time frame: 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. 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.

  4. Digit Span Backward

    Time frame: 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 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.

  5. Rey-Osterrieth Complex Figure Test - Delayed Recall

    Time frame: 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. 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.

  6. The Digit Symbol Substitution Test

    Time frame: 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. Total Range 0 (minimum) - 135 (maximum). Larger numbers indicate better performance.

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.