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

NCT ID: NCT03375151

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EEG based feedback

Intervention Type DEVICE

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.

Standard practice based feedback

Intervention Type BEHAVIORAL

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.

Standard practice based feedback

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

Group Type OTHER

Standard practice based feedback

Intervention Type BEHAVIORAL

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.

No feedback

The participants will perform the exercise without feedback during practice.

Group Type OTHER

No feedback

Intervention Type BEHAVIORAL

Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

No feedback

Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brainmarc Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Dvir, Dr.

Role: PRINCIPAL_INVESTIGATOR

Reuth rehabilitation medical center

Central Contacts

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Goded Shahaf, Dr.

Role: CONTACT

Phone: 97246660676

Email: [email protected]

Other Identifiers

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CLD13

Identifier Type: -

Identifier Source: org_study_id