Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes in Rey Auditory Verbal Learning Test Score
研究概览
简要总结
This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI). The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. 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 word retrieval and other cognitive functions in patients with MCI. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.
详细描述
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMa/DaCC region and its influence on word retrieval and other cognitive functions in patients with MCI after 10 sessions of HD-tDCS. There will be two treatment arms: active HD-tDCS (1 mA) and a sham group. For Phase 1, participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) or sham across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months and receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition in Phase 1. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition. Questionnaires will be completed examining how well the participants and outcomes assessors were blinded in Phase 1. During Phase 2, individuals who were assigned to the sham condition will be unblinded following all assessments as they will be given the option to return for the active condition. Study team members will become unblinded as a result.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active diagnosis of mild cognitive impairment, Female and male subjects, All races/ethnicities, Age 55 years and older, Fluent in English,
排除标准
- •Lifetime history of major neurologic syndromes (e.g., epilepsy, brain tumor, etc), Substance use disorder within the past year, Has metal fragments in skull/head, Current vision or hearing impairment that interferes with testing, Current medication use known to alter HD-tDCS reactivity
研究组 & 干预措施
Phase 1: Sham Treatment
Participants will receive 10 sessions of sham stimulation across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
干预措施: Sham Treatment (Device)
Phase 1: Active Treatment
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
干预措施: NeuroElectric StarStim (Device)
Phase 2: Active Treatment
For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.
干预措施: NeuroElectric StarStim (Device)
结局指标
主要结局
Changes in Rey Auditory Verbal Learning Test Score
时间窗: Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment
The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 20 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of the condition will be examined as well as from baseline to 8 months post-treatment. RAVLT : Rey Auditory Verbal Learning Test, 0-15 score for each trial, higher scores reflect better performance
次要结局
- Changes in Boston Naming Test Short Form(Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment)
- Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test(Pre-treatment, post-treatment (an average of 2 weeks), and 8 weeks post-treatment)
研究者
Christian Lobue
ASSOCIATE PROFESSOR - Psychiatry
University of Texas Southwestern Medical Center