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临床试验/NCT03723850
NCT03723850已完成不适用

Effect of Noninvasive Electrical Brain Stimulation on Memory Performance at Different Times of Day in Younger and Older Adults

University of Chicago1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2019年3月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
271
试验地点
1
主要终点
Episodic Memory Performance

研究概览

简要总结

This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts memory performance as a function of time-of-day in younger and older adults.

详细描述

Transcranial Direct Current Stimulation (tDCS) is the safest and most accessible, non-invasive brain stimulation technique available for testing causal links between different brain regions and functions, by manipulating cognitive abilities. By identifying key experimental factors that can improve the reliability and robustness of stimulation effects on cognitive performance in different age groups, this project should lead to the widespread adoption of these design features in future applications. This study will investigate the extent to which tDCS to dorsolateral prefrontal cortex (or dlPFC) impacts recollection accuracy and working memory performance as a function of time-of-day in younger and older adults. Moreover, this study will test the extent that tDCS to dlPFC impacts memory performance by impacting information-specific processes and/or cognitive control processes that operate across different types of information, thereby informing basic theories of how dlPFC contributes to memory in younger and older adults.

研究设计

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

盲法说明

Neither the participant, nor the research assistant administering tDCS will know if the participant is receiving active tDCS or sham tDCS.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Right-handed (according to the Edinburgh Handedness Inventory)
  • •Normal or corrected vision
  • •Fluent in English (started learning by age 6)
  • •Ability to understand and provide informed consent for study procedures, and to comply - with study procedures for the entire length of the study.
  • •For individuals in the 'younger adults' group, must be between 18 and 30 years of age
  • •For individuals in the 'older adults' group, must be between 60 and 75 years of age
  • •A score of 23 or above on the Montreal Cognitive Assessment (out of 30, education-corrected) is required. This is to minimize the inclusion of suspected mild cognitive impairment (MCI) or dementia, targeting individuals that score in the normal range according to the recent meta-analysis of MoCA's ability to differentiate normal aging from MCI in Carson et al. (2018, Int. J of Geriatric Psychiatry).
  • •Performance above threshold on the episodic memory task during the baseline session. The threshold is defined as having a hit rate that is at least 5% greater than the false alarm rate, where hit rate is defined as the number of studied items identified as studied, divided by the total number of studied items, and false alarm rate is defined as the number of new items identified as studied, divided by the total number of new items. We don't anticipate this threshold to exclude many, if any subjects.

排除标准

  • •Neuropsychological conditions associated with cognitive decline or seizure
  • •Cochlear implants or metal in the brain/skull (except titanium)
  • •Psychoactive medications, or diagnosis of depression, bipolar disorder, or any psychotic diagnoses
  • •History of excessive use (clinically treated) alcohol or narcotics
  • •Hospitalization for head trauma (e.g. concussions) in the past 5 years
  • •Individuals above a threshold score on an assessment of depression, specifically, a score of 10 or above on the Patient Health Questionnaire (PHQ-9)(Manea et al., 2012)
  • •Risk of pregnancy
  • •Low tolerance of skin irritation
  • •Prior brain stimulation experience (self-report)
  • •Ongoing cognitive or sensory deficits/symptoms from a previous (or current) COVID-19 infection.

研究组 & 干预措施

Older, active tDCS, dlPFC

Experimental

Older adults (ages 60-75) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

2.

干预措施: Active tDCS (Device)

Older, sham tDCS, dlPFC

Sham Comparator

Older adults (ages 60-75) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

干预措施: Sham tDCS (Device)

Younger, active tDCS, dlPFC

Experimental

Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left dorsolateral prefrontal cortex. One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

干预措施: Active tDCS (Device)

Younger, sham tDCS, dlPFC/parietal

Sham Comparator

Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of sham tDCS stimulation (Soterix Medical) delivered to either the left dorsolateral prefrontal cortex (area F3 using the 10-20 EEG system, n = 25), or the left parietal cortex (area P5 using the 10-20 EEG system, n = 25). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

干预措施: Sham tDCS (Device)

Younger, active tDCS, parietal cortex

Active Comparator

Younger adults (ages 18-30) randomized to this arm will receive 2 sessions of active tDCS stimulation (Soterix Medical) delivered to the left parietal cortex (area P5 using the 10-20 EEG system). One session will occur in the morning (8 or 9am) and one will occur on a separate day in the afternoon (3 or 4pm).

干预措施: Active tDCS (Device)

结局指标

主要结局

Episodic Memory Performance

时间窗: This task is performed immediately after tDCS is administered, and lasts approximately 20 minutes.

To measure episodic memory performance, participants will perform a recollection task. They will first study picture and word stimuli (encoding phase). On the subsequent memory test (retrieval phase), participants will be asked to differentiate between studied and non-studied items, as well as recollecting the previous format for studied items (i.e. recollecting the picture or word). For each tested item, participants will also be asked to make a confidence judgement about their response. The primary dependent variable (DV) will be the proportion of studied items attributed to the correct source minus the proportion of nonstudied items incorrectly attributed to that same source.

次要结局

  • Working Memory Performance(This task lasts approximately 10 minutes and is performed immediately after the episodic memory task (approximately 20 minutes after the end of the tDCS session).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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