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临床试验/NCT02851511
NCT02851511已完成不适用

Augmenting Cognitive Training In Older Adults

University of Florida3 个研究点 分布在 1 个国家目标入组 379 人开始时间: 2017年8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
379
试验地点
3
主要终点
Improvement in Cognitive Ability.

研究概览

简要总结

A two-phase adaptive randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance neurocognitive function, brain function, and functional outcomes from CT, with combined CT and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12 months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs. active cognitive tasks will predict individual response to tDCS.

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
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 89 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 65 to 89 years; this age group was selected because it is at high risk of age-related cognitive decline and have a sufficiently long life expectancy to participate in the study.
  • •Evidence of age-related cognitive decline in the Cognitive Training assessment defined by performance below the 80th percentile.
  • •Ability to participate in the intervention and attend training sessions; willingness to be randomized to either treatment group.

排除标准

  • •Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
  • •Evidence of cognitive impairment (as defined by NACC UDS performance below 1.5 standard deviations on age/sex/education normative data in at least one cognitive domain).
  • •Past opportunistic brain infection.
  • •Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality.
  • •Unstable (e.g., cancer other than basal cell skin) and chronic (e.g. severe diabetes) medical conditions.
  • •MRI contraindications (e.g., claustrophobia, metal implants).
  • •Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
  • •Currently on GABA-ergic or glutamatergic medications, or on sodium channel blockers.
  • •Left-handedness.

研究组 & 干预措施

Cognitive Training + Active Stimulation

Experimental

This arm receives cognitive training combined with active tDCS.

干预措施: Cognitive Training (Behavioral)

Cognitive Training + Active Stimulation

Experimental

This arm receives cognitive training combined with active tDCS.

干预措施: tDCS (active stimulation) (Device)

Cognitive Training + Sham Stimulation

Experimental

This arm receives cognitive training combined with sham tDCS.

干预措施: Cognitive Training (Behavioral)

Cognitive Training + Sham Stimulation

Experimental

This arm receives cognitive training combined with sham tDCS.

干预措施: tDCS (sham stimulation) (Device)

Educational Training + Active Stimulation

Experimental

This arm receives educational training combined with active tDCS.

干预措施: tDCS (active stimulation) (Device)

Educational Training + Active Stimulation

Experimental

This arm receives educational training combined with active tDCS.

干预措施: Educational Training (Behavioral)

Educational Training + Sham Stimulation

Experimental

This arm receives educational training combined with sham tDCS.

干预措施: tDCS (sham stimulation) (Device)

Educational Training + Sham Stimulation

Experimental

This arm receives educational training combined with sham tDCS.

干预措施: Educational Training (Behavioral)

结局指标

主要结局

Improvement in Cognitive Ability.

时间窗: Change from baseline to post assessment (3 months).

Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).

次要结局

  • Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)(Baseline to post assessment (3 months).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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