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

NCT06840808 | Completed FDA Device

• 3 other identifiers: STU2022-0999/23-23123-231STU2022-0999
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Word Finding Difficulty; Acquired Brain Injury; Traumatic Brain Injury

Keywords

electroencephalography; transcranial direct current stimulation; Cognition

Outcome Measures

Primary Outcomes (4)

• 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

  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. Metric: Number of Correct Items Generated.

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

• 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.

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

• 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

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

Secondary Outcomes (6)

• The Trail Making Test (Parts A & B)

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

• Digit Span Forward & Backward

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

• Rey-Osterrieth Complex Figure Test

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

• The Digit Symbol Substitution Test

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

• 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.

Study Arms (2)

Active to Sham Transcranial direct current stimulation

EXPERIMENTAL

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; Device: Sham Transcranial direct current stimulation

Sham to Active transcranial direct current stimulation

EXPERIMENTAL

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; Device: Sham Transcranial direct current stimulation

Interventions

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.

Active to Sham Transcranial direct current stimulation; Sham to Active transcranial direct current stimulation

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.

Active to Sham Transcranial direct current stimulation; Sham to Active transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

The University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

Related Publications (3)

• 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.

  PMID: 31354040 BACKGROUND

• 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.

  PMID: 34478816 BACKGROUND

• 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.

  PMID: 36108520 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Anomia; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Hart, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: December 1, 2024
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)