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临床试验/NCT04647032
NCT04647032已完成不适用

Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Divided Attention Performance

研究概览

简要总结

The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).

详细描述

30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Grade 12 or more education
  • Normal or corrected to normal vision and hearing
  • Ability to complete cognitive tasks
  • Ability to cooperate and comply with all study procedures
  • Ability to tolerate tACS
  • Montreal Cognitive Assessment score: 17-28
  • -1 z-score on immediate memory, delayed memory, fluency, processing speed, or task switch
  • Self-reported memory complaint

排除标准

  • Neurological or psychiatric disorders other than mild cognitive impairment
  • Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
  • Family history of epilepsy
  • Implanted electronic devices (e.g., pacemaker)
  • Prior head trauma
  • Taking cholinesterase inhibitory, memantine, or psychotropic medication
  • Taking anti-depressants or anti-anxiety medication
  • Color blind
  • Substance abuse
  • Macular degeneration
  • Amblyopia (lazy eye)
  • Strabismus (crossed eyes)

结局指标

主要结局

Divided Attention Performance

时间窗: Post-tACS (1-month follow-up), approximately 1 month after baseline

Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.

Sustained Attention Performance

时间窗: Post-tACS (1-month follow-up), approximately 1 month after baseline

Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.

Working Memory Performance

时间窗: Post-tACS (1-month follow-up), approximately 1 month after baseline

Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares

次要结局

  • Instrumental Activities of Daily Living (IADL)(Post-tACS (1-month follow-up), approximately 1 month after baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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