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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas at Dallas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Transcranial direct current stimulationExperimental treatment 1 intervention
Group B: Sham transcranial direct current stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
2

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.

Time frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
3

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.

Time frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
4

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.

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

Secondary outcomes

1

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.

Time frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
2

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.

Time frame
Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
3

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.

Time frame
Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
4

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.

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

Other outcomes

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