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临床试验/NCT03447236
NCT03447236已完成不适用

An Evaluation of Changes in Brain Functional Connectivity Resulting From Cognitive Intervention by Means of the Feuerstein Instrumental Enrichment Program in Older People With Mild Cognitive Impairment (MCI)

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年7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
已完成
入组人数
28
试验地点
1
主要终点
Change from baseline functional connectivity

研究概览

简要总结

Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above. The program is an applied practicable program based on the theories of Structural Cognitive Modifiability as well as on a Mediated Learning Experience. The program takes into consideration the unique characteristics and requirements of the older population. The program is composed of a variety of cognitive tasks that offer systematic activities intended to stimulate mental and cognitive development.

Objective: To examine the influence of the Feuerstein Program on brain functional connectivity as measured by MRI assessments and cognitive function of participants suffering from Mild Cognitive Impairment (MCI).

Hypothesis: The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity.

Methods: Residents of retirement homes will be offered to participate in the study. Participants will undergo cognitive and MRI assessments prior to and following a period of cognitive intervention using the Feuerstein Instrumental Enrichment Program.

详细描述

Introduction

In recent decades, with the increase in life expectancy, the number of older people and their relative rate within the population have risen dramatically. This trend led to increased rates of people suffering from a mild cognitive disorder and dementia in developed countries. Mild Neurocognitive Disorder or Mild Cognitive Impairment (MCI) is defined as a transition state between successful aging and a state of dementia. This state is characterized by cognitive impairment and a decline in memory skills while daily functioning is maintained.

Older people diagnosed with MCI are at increased risk of developing dementia, particularly Alzheimer's disease. This risk is ranked at about 12% every year.

Since this is a pre-dementia stage, great importance lies in finding methods that may prevent or at least decelerate the progress of MCI to dementia. Cognitive training is believed to be an appropriate intervention for preserving cognitive function.

The Feuerstein Program

研究设计

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

入排标准

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

入选标准

  • •Aged 60 and above.
  • •Hebrew speakers.
  • •Expressing willingness to participate in the research and deliberately signing a consent form.
  • •A diagnosis of MCI exists according to accepted clinical criteria - the examinee's score in the MoCA Test is within the range of 18-26 (inclusive).

排除标准

  • •A medical or functional condition that will not allow the subject to participate in the intervention program within the research period.
  • •Diagnosed subjects suffering from active depression, bipolar disorder or schizophrenia.
  • •Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
  • •Visual impairment that will not allow subjects to observe detailed information on a 32' screen from a distance of 1 meter.
  • •Hearing impairment that will not allow subjects to listen to instructions during assessment.
  • •Subjects whose MoCA Test's score is 17 and below or 27 and above.
  • •Subjects unable to undergo MRI assessments based on a standard questionnaire of eligibility for MRI excluding the use of metal and electronic implants.
  • •Subjects who will decide not to participate following a 10 minute MRI scan which will allow subjects to experience the procedure.
  • •The finding of a Random Space Occupying Lesion on MRI scan at initial anatomical assessment.

研究组 & 干预措施

Feuerstein Program

Experimental

All subjects participating in the Feuerstein Program will be evaluated by anatomical and functional MRI as well as computerized cognitive assessment prior to and following intervention as outlined in the protocol.

干预措施: Feuerstein Program (Behavioral)

结局指标

主要结局

Change from baseline functional connectivity

时间窗: Through study completion, an average of 11 months

Based on correlation coefficient of FMRI signal between brain regions

次要结局

  • Change from baseline cognitive function(Through study completion, an average of 11 months)

研究者

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

Tzvi Dwolatzky

Director Geriatrics

Rambam Health Care Campus

研究点 (1)

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