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

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: No feedback; Device: EEG based feedback; Behavioral: Standard practice based feedback

• Registration Number: NCT03375151
• Lead Sponsor: Brainmarc Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-15
• Last Update Posted: 2017-12-15
• Study Start: 2018-02
• Primary Completion: 2019-02
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No feedback	No feedback	The participants will perform the exercise without feedback during practice.
EEG based feedback	EEG based feedback	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.
EEG based feedback	Standard practice based feedback	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.
Standard practice based feedback	Standard practice based feedback	The therapist will give feedback to the participants during the exercise based on their performance.

Primary Outcome Measures

Name	Time	Method
Cognitive test grade	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.

Secondary Outcome Measures

Name	Time	Method
Rey Auditory-Verbal Learning Test	up to 5 weeks	The difference in grades of Free And Cued Selective Reminding Test (FCSRT) score between the beginning and the end of the study.
Clinical Global Impression of Change	up to 5 weeks	The difference in grades of Clinical Global Impression of Change (CGI-C) score between the beginning and the end of the study.
Rivermead Behavioral Memory Test	up to 5 weeks	The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.
Free And Cued Selective Reminding Test	up to 5 weeks	The difference in grades of Rey Auditory-Verbal Learning Test (RAVLT) score between the beginning and the end of the study.