Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (HDtDCS-CTBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The Controlled Oral Word Association Test
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., pre-supplementary motor area) thought to aid in memory will improve verbal retrieval in civilian (non-military, non-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, concussion history, structural brain imaging, and EEG 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 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and 2-month follow-up testing sessions, participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at 2-months follow-up testing sessions.
Civilians 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 session 10 and one time following treatment competition (i.e., 2-months). For participants who complete the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again after treatment session 10 and one time following competition of the second treatment (i.e., 2-months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-85
- •Traumatic brain injury more than a year prior to study participation
- •Word finding difficulty since the brain injury
- •Fluent in speaking and reading English.
排除标准
- •Implanted/electronic device, such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.).
- •Skull defects
- •History of a psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders, 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.
- •Inability to give informed consent
- •Military personnel or Veteran
- •Currently pregnant
- •Not fluent English speaker
研究组 & 干预措施
Active to Sham Transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
干预措施: Active Transcranial direct current stimulation (Device)
Active to Sham Transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.
干预措施: Sham Transcranial direct current stimulation (Device)
Sham to Active transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
干预措施: Active Transcranial direct current stimulation (Device)
Sham to Active transcranial direct current stimulation
Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.
干预措施: Sham Transcranial direct current stimulation (Device)
结局指标
主要结局
The Controlled Oral Word Association Test
时间窗: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test, including both letter and category fluency. Metric: Number of Correct Items Generated
The Boston Naming Test
时间窗: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.
Rey Auditory Verbal Learning Test and alternative lists
时间窗: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.
The Delis Kaplan Color Word Interference Test
时间窗: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
次要结局
- Rey-Osterrieth Complex Figure Test(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
- The Digit Symbol Substitution Test(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
- The Trail Making Test (Parts A & B)(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
- Digit Span Forward & Backward(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
- Task-based electroencephalography (EEG) markers during a Go-NoGo task(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
- Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task(Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.)
研究者
John Hart, Jr.
Professor
The University of Texas at Dallas