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

NCT05408975 | Completed Results FDA Device

• 3 other identifiers: 23-2311K99DC020185-01A15K99DC020185-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

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

Keywords

transcranial direct current stimulation; electroencephalography; Cognition

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (6)

• The Trail Making Test - Part A

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

• The Trail Making Test - Part B

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

• Digit Span Forward

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

• Digit Span Backward

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

• Rey-Osterrieth Complex Figure Test - Delayed Recall

  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

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

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.

Also known as: tDCS, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10

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 not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

The University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Anomia; Brain Injuries

Interventions

Transcranial Direct Current Stimulation

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Hsueh-Sheng Chiang
• Organization: Beth Israel Deaconess Medical Center

hchiang3@bidmc.harvard.edu

6176674074

Study Officials

• John Hart, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 2, 2022
• First Posted: June 7, 2022
• Study Start: January 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Locations

US (2)