Treatment of Verbal Retrieval Deficits in Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment group differences in change from Baseline to 3-months Post-Treatment in Category Fluency
时间窗: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
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 2-months Post-Treatment on the Controlled Oral Word Association Test
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
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 on the Controlled Oral Word Association Test
时间窗: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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 3-months Post-Treatment on the Boston Naming Test
时间窗: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment
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
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
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.
次要结局
- 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)
- Treatment group differences in change from Baseline to 3-months Post-Treatment on the Digit Span Backward(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 Grooved Pegboard Test(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 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 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test(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 2-months Post-Treatment on the Digit Span Forward(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 2-months Post-Treatment on the Digit Span Backward(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 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test(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 2-months Post-Treatment on the Digit Symbol Substitution Test(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(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 3-months Post-Treatment on the Rey-Osterrieth Complex Figure Test(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 3-months Post-Treatment on the Digit Symbol Substitution Test(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 3-months Post-Treatment on the Grooved Pegboard Test(Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment)
研究者
John Hart, Jr.
Professor
The University of Texas at Dallas