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Traumatic Brain InjuryNCT06840808

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

A study testing Active Transcranial direct current stimulation in people with Traumatic Brain Injury and Cognitive Change, run by The University of Texas at Dallas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Active Transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
1 Dec 2024to 12 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas at Dallas

    Richardson, Texas, 75080

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Active Transcranial direct current stimulation, Sham Transcranial direct current stimulation
Keywords
electroencephalography, transcranial direct current stimulation, Cognition
Medical subject headings
Brain Injuries, Traumatic, Anomia, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Transcranial direct current stimulationDevice

    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 stimulationDevice

    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.

Study groups in NCT06840808
Study groupRoleWhat they receive
Active to Sham Transcranial direct current stimulationExperimentalSubjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
Receives: Device: Active Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation
Sham to Active transcranial direct current stimulationExperimentalSubjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
Receives: Device: Active Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Controlled Oral Word Association Test

    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

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  2. The Boston Naming Test

    Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  3. Rey Auditory Verbal Learning Test and alternative lists

    Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  4. The Delis Kaplan Color Word Interference Test

    Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Secondary outcomes (6)
  1. The Trail Making Test (Parts A & B)

    Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  2. Digit Span Forward & Backward

    Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  3. Rey-Osterrieth Complex Figure Test

    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

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

  4. The Digit Symbol Substitution Test

    Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

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

    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.

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

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

    Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes.

    Measured: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start1 Dec 2024
  3. Primary completion12 Nov 2025
  4. Study completion12 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840808
Sponsor's protocol ID
STU2022-0999/23-231
Other IDs
23-231, STU2022-0999
Status last verified
Feb 2026
First submitted
17 Feb 2025
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Will share data upon request.

Publications

  • 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.

    PubMed 31354040
  • 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.

    PubMed 34478816
  • 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.

    PubMed 36108520

Questions about this trial

What is this clinical trial studying?

A study testing Active Transcranial direct current stimulation in people with Traumatic Brain Injury and Cognitive Change, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Controlled Oral Word Association Test (time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840808, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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