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临床试验/NCT04020744
NCT04020744已完成不适用

Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems

University of Bern2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年7月1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
84
试验地点
2
主要终点
Rate of change in hippocampal activity during a memory task

研究概览

简要总结

Increased activity in the hippocampus (i.e., hyperactivity) during a fMRI memory task was found in patients with Mild Cognitive Impairment due to Alzheimer's disease (MCI). Those with increased hippocampal activity exhibited elevated clinical progression. Reducing hippocampal hyperactivity with pharmacological treatment reduced hyperactivity and improved memory performance. The investigators of this study will test whether real-time fMRI neurofeedback will also downregulate hippocampal activity and thereby improve memory performance.

详细描述

Alzheimer's disease (AD) is an insidious and progressive neurodegenerative disorder accompanied by extracellular deposits of beta-amyloid ( aβ) and the increase of cognitive dysfunctions. Several functional magnet resonance imaging (fMRI) studies in the prodromal stage of AD (i.e., in MCI) have found increased hippocampal activity during a memory task to be predictive of memory worsening and disease progression. In this study the investigators are aiming to reduce hippocampal hyperactivity with real-time fMRI neurofeedback and test whether this will improve memory performance.

This study will use a randomized, single-blind, parallel group design. Patients with MCI and healthy participants will be assigned to receive feedback from either the hippocampus (experimental group, N=42) or from another brain area (alternate ROI feedback group, N=42). All participants will be instructed to downregulate activity.

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
Single (Participant)

盲法说明

For blinding of the participants, they will be told that they will be asked to regulate one of two brain regions, without mentioning the specific area.

入排标准

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

入选标准

  • •Intact activities of daily living
  • •Fluent in German
  • •Normal/corrected-to-normal vision
  • •Written informed consent

排除标准

  • •Current/lifetime severe psychiatric or neurological disorder
  • •History of seizures
  • •Psychotropic medication
  • •Currently/lifetime drug or alcohol abuse
  • •Brain damage
  • •Magnetisable implants

研究组 & 干预措施

healthy elderly participants receiving feedback from the hippocampus

Active Comparator

This group will consist of healthy elderly volunteers, who will receive feedback from their hippocampal activity.

干预措施: real-time fMRI based neurofeedback from the hippocampus (Other)

healthy elderly participants receiving feedback from another area

Sham Comparator

This group will consist of healthy elderly volunteers, who will receive feedback from another brain area.

干预措施: real-time fMRI based neurofeedback from another brain area (Other)

patients with MCI receiving feedback from the hippocampus

Experimental

This group will consist of patients with mild cognitive impairment, who will receive feedback from their hippocampal activity.

干预措施: real-time fMRI based neurofeedback from the hippocampus (Other)

patients with MCI receiving feedback from another brain area

Sham Comparator

This group will consist of patients with mild cognitive impairment, who will receive feedback from another brain area.

干预措施: real-time fMRI based neurofeedback from another brain area (Other)

结局指标

主要结局

Rate of change in hippocampal activity during a memory task

时间窗: Directly after the intervention

Measured by fMRI (rate of change in activity from baseline to after the intervention)

次要结局

  • Rate of change in memory performance(Directly after the intervention)
  • Rate of change from in memory performance (behavioural)(Directly after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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