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

Официальное название

Treatment of Verbal Retrieval Deficits in Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство Transcranial direct current stimulation
  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 seco
• Устройство sham tDCS
  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

Первичные конечные точки

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Controlled Oral Word Association Test [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment]

Вторичные конечные точки (12)

• Treatment group differences in change from Baseline to 3-months Post-Treatment on the Trail Making Test (Part A) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 Delis Kaplan Color Word Interference Test [Срок оценки: 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 Digit Span Forward [Срок оценки: 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 Digit Span Forward [Срок оценки: 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 Digit Span Backward [Срок оценки: 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 Digit Span Backward [Срок оценки: 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 Rey-Osterrieth Complex Figure Test [Срок оценки: 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 Rey-Osterrieth Complex Figure Test [Срок оценки: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas at Dallas — Dallas

Идентификаторы

NCT: NCT04869059 · UTD-TDCSTBI-21-15 · CDMRP-PT190081 · W81XWH-20-1-0846

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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