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临床试验/NCT06235970
NCT06235970招募中不适用

Cognitive Enhancement Through Model-based and Individualized Neurostimulation

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
EEG Markers

研究概览

简要总结

The goal of this clinical trial is to learn about the effects of transcranial electric stimulation on attentional control and brain dynamics in healthy adults. The main questions are:

Does stimulation affect how subjects exert attentional control? Do mathematical models predict brain activity changes in response to stimulation?

Participants will have electroencephalography (EEG) brain data recorded while:

They sit relaxed They receive stimulation, while relaxed They receive stimulation while completing computerized tasks to measure cognitive abilities ("cognitive tasks") They receive sham (ineffective) stimulation during cognitive tasks

详细描述

The purpose of this research is to compare the effects of different transcranial electrical stimulation (tES) protocols on both EEG and behavioral markers associated with attention and cognitive control. Both conventional tES protocols (tDCS, tACS) will be compared with customized stimulation waveforms derived from an individualized whole-brain neural model (MINDy), and with periods of sham or no-stimulation.

Non-invasive brain stimulation approaches hold great promise as an intervention to enhance cognitive and brain function in humans, both in clinically impaired and even healthy young adult populations. Transcranial electrical stimulation, known as tES, refers to a family of methods that utilize low-cost technologies and involve low-intensity currents which are safe for humans, and carry minimal risk of side effects or adverse events. Conventional approaches, which utilize fixed direct currents (tDCS) or alternating currents at a fixed oscillatory frequency (tACS), have been widely used as both a basic research tool and as a clinical intervention. However, current literature suggests that tES may be more effective when deployed with stimulation protocols that are: 1) personalized (i.e., respecting individual differences in brain anatomy and function); and 2) informed by an understanding of the mechanisms that govern brain network activation dynamics and interactions.

The investigators will use a single-group design in which 60 healthy young adults receive different stimulation protocols, (plus an additional 10-12 recruited during the initial pilot testing phase), randomized within-subject during either resting- state (Aims 1, 2) or cognitive task conditions (Aim 3), while brain activity is monitored with electroencephalography (EEG). During the EEG recording periods, stimulation epochs will be randomly intermixed with epochs of sham or no- stimulation, with participants masked to the condition. Additionally, conventional stimulation protocols (tDCS, tACS) will be compared with customized stimulation waveforms derived from an individualized whole-brain neural model.

The study will consist of two EEG+tES sessions each lasting approximately one hour, and occurring on separate days.

Outcomes will be assessed in terms of different EEG markers, including spectral power both at the stimulation site and at target brain networks associated with attention and cognitive control (frontoparietal [FPN] and default mode [DMN] networks). Behavioral performance will also be assessed on a well-established experimental task (AX-CPT) that manipulates attention and cognitive control demands, in terms of key accuracy and reaction time performance indices.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy younger adults (ages 18 to 45). Community-living men, women or non-binary, aged 18-45
  • Exclusion criteria:
  • Taking psychotropic medication or medication with cognitive side effects
  • Medical disorder that affects cognitive or motor function
  • Past/present head injury associated with loss of consciousness or neurological sequelae
  • Prior occurrence of seizure of any origin
  • Skin conditions affecting the scalp
  • Scalp tattoos
  • Rashes, sores or open wounds on scalp or face

排除标准

  • 未提供

研究组 & 干预措施

Device: Transcranial electrical stimulation (tES) including SHAM

Experimental

healthy adults

干预措施: Transcranial electrical stimulation (tES) including SHAM (Device)

结局指标

主要结局

EEG Markers

时间窗: Assessed concurrently during each of two 1-hour experimental sessions

Spectral power at stimulation site and within target networks (frontoparietal, default mode): EEG oscillatory power in the beta frequency band over frontal electrodes and theta frequency power over midline electrodes during the delay and response periods, averaged over trial-types. We will also measure the difference in posterior alpha power between the Acue and Bcue trials-types during the delay period.

次要结局

  • Cognitive task accuracy(Assessed concurrently during each of two 1-hour experimental sessions)
  • Cognitive task speed(Assessed concurrently during each of two 1-hour experimental sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Braver

Principal Investigator

Washington University School of Medicine

研究点 (2)

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