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临床试验/NCT04050046
NCT04050046已完成不适用

Noninvasive Brain Stimulation to Enhance Cognitive Training and Assess Neuroplasticity in Older Adults

University of Pennsylvania0 个研究点目标入组 28 人开始时间: 2015年8月18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
28
主要终点
Executive Function

研究概览

简要总结

This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. The investigators aim to enhance participants ability to perform tasks of memory, attention, processing speed and other areas of cognition. Additionally, researchers are interested in the ability of the brain to adapt to change-neuroplasticity. Neuroplasticity is thought to impact how individuals respond to cognitive training and tDCS. In order to look at individual differences in neuroplasticity transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, will be used. Individual responses to TMS can be used as a marker of neuroplastic changes in brain function, in order to reveal the relationship between brain plasticity and tDCS-induced changes in cognitive ability.

详细描述

Promising evidence suggests that cognitive training regimens may have some beneficial effects on cognition in older adults. However, the improvement from computer-based cognitive training (CBCT) diminish over time which highlights a fundamental challenge for CBCT interventions. Transcranial direct current stimulation (tDCS) can enhance certain cognitive skills, particularly when stimulation is combined with rehearsal of relevant behaviors. Importantly, these benefits have been shown to persist up to 2 months after the intervention.

This study will lay the groundwork for larger scale studies that will combine CBCT with neuromodulation, potentially leading to the development of a persistent, transferrable, multimodal technique to preserve cognition in older adults. In this study, participants will be randomly assigned to receive either real or sham tDCS for 5 consecutive days in conjunction with CBCT. The participant's cognition will be assessed with a neuropsychological assessment at baseline, 1 week, 2 weeks, and 2 months in order to determine any changes.

Additionally, transcranial magnetic stimulation (TMS) will be used to characterize the relationship between baseline differences in brain plasticity and cognitive changes induced by tDCS+CBCT. The effects of TMS on cortical activity have been shown to depend on a variety of neuroplasticity-related mechanisms. In this study, changes in motor physiology (called motor evoked potentials (MEPs)) induced by TMS will be used. Stimulation of the motor cortex with TMS induces robust, transient, and readily quantifiable changes in motor excitability, which are sensitive to changes in the mechanisms of neuroplasticity. Investigators hypothesize that individual variability in brain plasticity, measured by changes in MEP response to TMS, will predict the degree of cognitive benefit afforded by tDCS+CBCT.

Study Visits:

---------------- Visit 1 - Consent and Screening (2 hours) Review enrollment documents and conduct baseline neuropsychological assessment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal cognition
  • English as their native language

排除标准

  • . History of neurological disorders
  • . History of head injury with unconsciousness lasting more than 5 minutes
  • . History of psychiatric disorders
  • . Currently abusing alcohol or drugs (prescription or otherwise)
  • . History of epilepsy or seizures within the past 6 months
  • . Previous brain surgery
  • . Pacemaker

结局指标

主要结局

Executive Function

时间窗: baseline, day 5, 2 week, 2 months

Change in tDCS induced executive function as measured by the Delis-Kaplan Executive Function Systems (DKEFS) test. DKEFS utilizes a scaled score which ranges from 1-20 with scores between 8-12 considered average.

次要结局

  • TMS brain activation(2 week)

研究者

申办方类型
Other
责任方
Sponsor

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