Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

NCT04869059 | Recruiting DMC FDA Device

• 3 other identifiers: UTD-TDCSTBI-21-15CDMRP-PT190081W81XWH-20-1-0846
• Study Type: interventional
• Target: 136
• 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., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military 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 and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; transcranial direct current stimulation; electroencephalography; cognition; veteran traumatic brain injury

Outcome Measures

Primary Outcomes (10)

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Controlled Oral Word Association Test

  Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on the Controlled Oral Word Association Test

  Evaluation of treatment group differences in change on the Control Word Association Test from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency

  Evaluation of treatment group differences in change in Category Fluency from baseline to 3-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency

  Evaluation of treatment group differences in change in Category Fluency from baseline to 2-months. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., \& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Semantic Object Retrieval Test

  Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 3-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test

  Evaluation of treatment group differences in change in Semantic Object Retrieval Test from baseline to 2-months. Metric: Number of Correct Retrievals Kaplan, E., Goodglass, H., \& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \& Febiger: Philadelphia.

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Boston Naming Test

  Evaluation of treatment group differences in change in Boston Naming Test from baseline to 3-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test

  Evaluation of treatment group differences in change in Boston Naming Test from baseline to 2-months. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment on California Verbal Learning Test

  Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 3-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test

  Evaluation of treatment group differences in change in California Verbal Learning Test from baseline to 2-months. Metric: Number of Correct Retrievals Delis DC, Kramer JH, Kaplan E, Ober BA. (2017). California verbal learning test (3rd Ed.). Pearson Publishing: San Antonio, TX.

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

Secondary Outcomes (16)

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A)

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part B)

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

• Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Delis Kaplan Color Word Interference Test

  Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions

Device: Transcranial direct current stimulation

Sham transcranial direct current stimulation

SHAM COMPARATOR

20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions

Device: sham tDCS

Interventions

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

Transcranial direct current stimulation

sham tDCS 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.

Sham transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The University of Texas at Dallas

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• John Hart, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashna Adhikari

CONTACT

972-883-3161; neurolab.memory@utdallas.edu

Jill Ritter, BS

CONTACT

972-883-3161; neurolab.memory@utdallas.edu

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: PARALLEL
• 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 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 3-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at 2- and 3-months follow-up testing sessions.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: May 3, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)