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

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: EEG based feedback; Behavioral: Standard practice based feedback; Behavioral: No feedback

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 120 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: EEG based feedback; Participants will participate in cognitive training sessions. The therapist will use feedback from the EEG analyzed data to direct the 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.; Behavioral: Standard practice based feedback; Participants will participate in cognitive training sessions. The therapist will give feedback to the participants during the exercise based on their performance only according to the his therapist standard practice.
Other: Standard practice based feedback; The therapist will give feedback to the participants during the exercise based on their performance.	Behavioral: Standard practice based feedback; Participants will participate in cognitive training sessions. The therapist will give feedback to the participants during the exercise based on their performance only according to the his therapist standard practice.
Other: No feedback; The participants will perform the exercise without feedback during practice.	Behavioral: No feedback; Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive test grade	The difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.	up to 5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brainmarc Ltd.
• Investigators: Principal Investigator: David Dvir, Dr., Reuth rehabilitation medical center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CLD13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No