High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Hopkins Verbal Learning Test-Revised Total Learning
研究概览
简要总结
The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 and older
- •Native English speakers
- •12 years of education or higher
- •Active diagnosis of aMCI
- •History of TBI based on VA/DOD criteria
排除标准
- •TBI within the past 2 years
- •Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
- •Lifetime history of epilepsy
- •Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
- •Substance use disorder
- •Has metal fragments in head
- •Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
结局指标
主要结局
Hopkins Verbal Learning Test-Revised Total Learning
时间窗: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up
Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance.
Hopkins Verbal Learning Test-Revised Delayed Recall
时间窗: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up
Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance.
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
时间窗: Baseline, immediately post-treatment, and a 3 -month follow-up
Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance.
Brief Visuospatial Memory Test-Revised Delayed Recall
时间窗: Baseline, immediately post-treatment, and a 3-month follow-up
Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance.
次要结局
- Phonemic Fluency(Baseline, immediately post-treatment, and a 3-month follow-up)
- Semantic Fluency(Baseline, immediate post-treatment, and a 3-month follow-up)
- Trail Making Test(Baseline, immediate post-treatment, and a 3-month follow-up)
- Stroop Color and Word Test(Baseline, immediate post-treatment, and a 3-month follow-up)
- Digit Span Test(Baseline, immediate post-treatment, and a 3-month follow-up)
研究者
Christian Lobue
Associate Professor
University of Texas Southwestern Medical Center