Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
研究概览
简要总结
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.
详细描述
This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.
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)
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
- •Fluent in English
- •Active diagnosis of MCI or dementia
排除标准
- •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
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
时间窗: Baseline, immediately following last treatment session, and 2-months post treatment
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 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 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.
次要结局
- Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the Boston Naming Test Short Form(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the Trail Making Test(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the Southwestern Assessment of Processing Speed(Baseline, immediately following last treatment session, and 2-months post treatment)
- Change in Score on the DKEFS Color-Word Interference Test(Baseline, immediately following last treatment session, and 2-months post treatment)
研究者
Christian Lobue
ASSISTANT PROFESSOR
University of Texas Southwestern Medical Center