search
Back to results

Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation (HDtDCS-TBI)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
sham tDCS
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, transcranial direct current stimulation, electroencephalography, cognition, veteran traumatic brain injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants are to be between the ages of 18-75, have previously served in the US armed services, and have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including, the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English.

Exclusion Criteria: Exclusion criteria include a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, severe traumatic brain injury, 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. Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram.

Sites / Locations

  • The University of Texas at DallasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A)
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part B)
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 3-months. Metric: Time to Name Items Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Name Items Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Forward
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Backward
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 3-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 2-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Symbol Substitution Test
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 3-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 2-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Grooved Pegboard Test
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 3-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.

Full Information

First Posted
February 10, 2021
Last Updated
July 28, 2023
Sponsor
The University of Texas at Dallas
search

1. Study Identification

Unique Protocol Identification Number
NCT04869059
Brief Title
Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
Acronym
HDtDCS-TBI
Official Title
Treatment of Verbal Retrieval Deficits in Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas at Dallas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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. Veterans 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 sessions 5, 10, and 15 and two times following treatment competition (i.e., 2-months and 3-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment sessions 5, 10, and 15 and two times following competition of the second treatment (i.e., 2-months and 3-months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic brain injury, transcranial direct current stimulation, electroencephalography, cognition, veteran traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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 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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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 Outcome Measure Information:
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Controlled Oral Word Association Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Controlled Oral Word Association Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment in Category Fluency
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Semantic Object Retrieval Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Boston Naming Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on California Verbal Learning Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on California Verbal Learning Test
Description
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.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Secondary Outcome Measure Information:
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A)
Description
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
Description
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part B)
Description
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 3-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
Description
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Description
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 3-months. Metric: Time to Name Items Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
Description
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months. Metric: Time to Name Items Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Forward
Description
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
Description
Evaluation of treatment group differences in change in Digit Span Forward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Backward
Description
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 3-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
Description
Evaluation of treatment group differences in change in Digit Span Backward from baseline to 2-months. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Description
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 3-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
Description
Evaluation of treatment group differences in change in Rey-Osterrieth Complex Figure Test scores from baseline to 2-months. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Symbol Substitution Test
Description
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 3-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
Description
Evaluation of treatment group differences in change on the Digit Symbol Substitution Test from baseline to 2-months. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Title
Treatment group differences in change from Baseline to 3-months Post-Treatment on the Grooved Pegboard Test
Description
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 3-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Time Frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
Title
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
Description
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Time Frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are to be between the ages of 18-75, have previously served in the US armed services, and have had a traumatic brain injury that has led to a verbal retrieval deficit based on neuropsychological testing criteria. Traumatic brain injury must be in the mild to moderate range based on evaluation, including, the Ohio State TBI Identification Method (administered by our research group). You must be fluent in speaking and reading English. Exclusion Criteria: Exclusion criteria include a history of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, severe traumatic brain injury, 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. Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mika Esquillo
Phone
972-883-3171
Email
neurolab@utdallas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Ritter, BS
Phone
972-883-3171
Email
neurolab@utdallas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hart, MD
Organizational Affiliation
University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mika Esquillo
Phone
972-883-3171
Email
neurolab@utdallas.edu
First Name & Middle Initial & Last Name & Degree
Ashna Adhikari
Phone
972-883-3171
Email
neurolab@utdallas.edu
First Name & Middle Initial & Last Name & Degree
Michael Motes, PhD
First Name & Middle Initial & Last Name & Degree
Gail Tillman, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs