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Completed

NCT Number: NCT06840808

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

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.

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Key information

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).

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).

Who can participate

Healthy volunteers accepted: No

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

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

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.

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, including both letter and category fluency. Metric: Number of Correct Items Generated

  2. 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. Metric: Number of Correct Items Generated.

  3. Rey Auditory Verbal Learning Test and alternative lists

    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.

  4. The Delis Kaplan Color Word Interference 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 Delis Kaplan Color Word Interference Test. Metric: Time to Name Items

Secondary outcomes

  1. The Trail Making Test (Parts A & 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

  2. Digit Span Forward & 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 Forward & Backward. Metric: Memory Span

  3. Rey-Osterrieth Complex Figure 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 Rey-Osterrieth Complex Figure Test scores. Metric: Score 0 to 36, the higher the better

  4. 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

  5. Task-based electroencephalography (EEG) markers during a Go-NoGo task

    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 EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes.

  6. Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task

    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 EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Official study title

Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (HDtDCS-CTBI)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 25, 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.

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