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

Brainmarc

Status

Unknown

Conditions

Mild Cognitive Impairment

Treatments

Behavioral: No feedback

Behavioral: Standard practice based feedback

Device: EEG based feedback

Study type

Interventional

Funder types

Industry

Identifiers

NCT03375151

CLD13

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65 to 120 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

EEG based feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Standard practice based feedback

Device: EEG based feedback

Standard practice based feedback

Other group

Description:

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

Treatment:

Behavioral: Standard practice based feedback

No feedback

Other group

Description: