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临床试验/NCT03375151
NCT03375151Unknown不适用

An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment

Brainmarc Ltd.0 个研究点目标入组 60 人开始时间: 2018年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Cognitive test grade

研究概览

简要总结

The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral recommendations for physical exercise. Some recommendations could also be found for cognitive practice. However, currently, there is no consensus regarding effective cognitive treatment or practice for MCI. Among the populations suffering from MCI, there is a significant segment of patients with amnestic disorder. For these patients, it seems that cognitive training of memory, including verbal memory, is very important. In recent years, we have developed an effective tool for managing rehabilitation practice by monitoring the patient's engagement with an easy-to-use EEG (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when the patient is recruited, the clinical improvement is significantly better. The aim of this study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve functional improvement in verbal memory training in patients with Amnestic MCI.

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
None

入排标准

年龄范围
65 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female above the age of 65 years
  • Ability to read, write and understand the Hebrew language so to comply with study demands.
  • Diagnosed with Amnestic MCI. Mini Mental State Examination (MMSE), A score of MSSE ≥27 for college educated subjects and MSSE ≥ 26 for all others; and (CDR) Clinical Dementia Rating, 0.5 ≥ CDR
  • Diagnosed with memory impairment, Visual Paired Association = VPA (WMS-R), for subjects of ages 65-70, 16.5 ≥ WMS-R and for subjects of age above 71, 15.5 ≥ WMS-R

排除标准

  • Diagnosed with major psychiatric or neurological disorder.
  • A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.

研究组 & 干预措施

EEG based feedback

Experimental

The therapist will give feedback to the participants during the exercise based on their performance.and use the feedback from the EEG analyzed data to direct cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise.

干预措施: EEG based feedback (Device)

EEG based feedback

Experimental

The therapist will give feedback to the participants during the exercise based on their performance.and use the feedback from the EEG analyzed data to direct cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise.

干预措施: Standard practice based feedback (Behavioral)

Standard practice based feedback

Other

The therapist will give feedback to the participants during the exercise based on their performance.

干预措施: Standard practice based feedback (Behavioral)

No feedback

Other

The participants will perform the exercise without feedback during practice.

干预措施: No feedback (Behavioral)

结局指标

主要结局

Cognitive test grade

时间窗: up to 5 weeks

The difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.

次要结局

  • Rey Auditory-Verbal Learning Test(up to 5 weeks)
  • Clinical Global Impression of Change(up to 5 weeks)
  • Rivermead Behavioral Memory Test(up to 5 weeks)
  • Free And Cued Selective Reminding Test(up to 5 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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