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临床试验/NCT04312126
NCT04312126招募中不适用

Mechanisms Underlying the Beneficial Effects of Naps on Motor Learning

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2021年3月4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
199
试验地点
1
主要终点
The primary endpoint measure is the degree to which motor skill consolidation (i.e., offline change in correct sequence typing speed) is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep (i.e. multiple r...

研究概览

简要总结

Background:

Memory consolidation is the process by which memories become stable, long-term representations in the brain. Consolidation of a motor skill is dependent upon sleep. Some research shows that daytime naps improve people s motor performance and memory retention. Researchers want to find out how daytime naps may contribute to learning and support consolidation of motor skill memories.

Objective:

To learn the role of memory replay during wakeful rest and sleep (naps) in retaining a newly learned skill.

Eligibility:

English-speaking adults ages 18 and older with chronic stroke, or healthy, right-handed, English-speaking adults ages 18-35 and 50-80

Design:

Participants will be screened with:

  • medical history
  • neurological history
  • medicine review
  • medical exam
  • neurological exam.

Participants will have a magnetic resonance imaging (MRI) scan of the brain. For this, they will lie down in a scanner. The scanner makes loud noises, so they will wear earplugs. They will fill out an MRI screening form before each MRI.

Participants will also have magnetoencephalography (MEG). MEG maps brain activity. It does this by recording the magnetic fields produced by naturally occurring electrical currents in the brain. For MEG, participants will lie down in the MEG room. Their eye movements may be recorded by a video camera.

Participants will have behavior testing. They will practice typing random keys. Then they will repeatedly type a custom sequence that they see on a computer screen. Then they will take a 2-hour nap. Then they will type the same sequence again.

Participants will have no more than 4 visits at the NIH over 3 months. Visits will last 2-4 hours each.

详细描述

Study Description:

We will investigate the within-individual contribution of wakeful and sleep neural replay to motor skill consolidation in three groups: (a) young healthy subjects, (b) older healthy subjects and (c) patients with chronic stroke.

Objectives:

The primary aim is to determine the relative contribution of neural replay during wakeful rest and sleep to consolidation of a newly learned skill in young and older healthy volunteers, and in chronic stroke patients with magnetoencephalography (MEG). The secondary aim is to evaluate differences in replay rates between these subject cohorts. We will also explore differences in replay rates, spatiotemporal dynamics of neural replay and sleep spindles to generate additional hypotheses and preliminary data for future studies.

Endpoints:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •HEALTHY VOLUNTEERS:
  • •INCLUSION CRITERIA:
  • •Age 18-35 (Arm 1) or 50-80 (Arms 2).
  • •English speaking.
  • •Clear right-hand dominance (>74 on Edinburgh Handedness Inventory).
  • •Normal neurological examination as determined by the screening clinician.

排除标准

  • •HCPS affiliated NIH staff (i.e. - staff from our section).
  • •Current pregnancy.
  • •Contraindications for MRI or MEG.
  • •Use of sleep medications within 24 hours of Experimental Session participation.
  • •Severe or progressive neurological, psychological or medical condition as determined by the screening clinician.
  • •STROKE PATIENTS:
  • •INCLUSION CRITERIA:
  • •Age 18 or older
  • •Willing and able to provide consent
  • •Experienced a stroke 6 months ago or more that affected at least one of the upper extremities at time of stroke diagnosis
  • •Ability to perform the study task as assessed during physical examination
  • •English-speaking
  • •EXCLUSION CRITERIA:
  • •HCPS-affiliated NIH staff (i.e. - staff from our section).
  • •Current pregnancy
  • •History of large stroke lesions in brainstem or cerebellum as determined by screening clinician
  • •Severe or progressive neurological disorder other than stroke (e.g., Parkinson s disease or multiple sclerosis) as determined by the screening clinician
  • •Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, psychiatric, sleep, or endocrine disorders as determined by the screening clinician
  • •Contraindications for MRI or MEG.

研究组 & 干预措施

Arm 1

46 healthy young (18-35) volunteers

Arm 3

46 chronic (>6 months post-stroke) stroke patients

干预措施: MRI system (Device)

Arm 3

46 chronic (>6 months post-stroke) stroke patients

干预措施: MEG system (Device)

Arm 2

46 healthy older (50-80) volunteers

结局指标

主要结局

The primary endpoint measure is the degree to which motor skill consolidation (i.e., offline change in correct sequence typing speed) is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep (i.e. multiple r...

时间窗: 4 years

The primary endpoint measure is the degree to which motor skill consolidation (i.e., offline change in correct sequence typing speed) is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep (i.e. multiple regression model with 3 predictors).

次要结局

  • Exploratory endpoints measures are spatial (i.e. - parcellated source space) and time-frequency maps of neural replay during wakeful rest and sleep.(4 years)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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