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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG based feedback
Standard practice based feedback
No feedback
Sponsored by
Brainmarc Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    Other

    Arm Label

    EEG based feedback

    Standard practice based feedback

    No feedback

    Arm 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.

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

    The participants will perform the exercise without feedback during practice.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Rivermead Behavioral Memory Test
    The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.
    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.

    Full Information

    First Posted
    December 13, 2017
    Last Updated
    December 13, 2017
    Sponsor
    Brainmarc Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03375151
    Brief Title
    An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
    Official Title
    An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2018 (Anticipated)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brainmarc Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EEG based feedback
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Standard practice based feedback
    Arm Type
    Other
    Arm Description
    The therapist will give feedback to the participants during the exercise based on their performance.
    Arm Title
    No feedback
    Arm Type
    Other
    Arm Description
    The participants will perform the exercise without feedback during practice.
    Intervention Type
    Device
    Intervention Name(s)
    EEG based feedback
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Standard practice based feedback
    Intervention Description
    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
    Intervention Name(s)
    No feedback
    Intervention Description
    Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.
    Primary Outcome Measure Information:
    Title
    Cognitive test grade
    Description
    The difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.
    Time Frame
    up to 5 weeks
    Secondary Outcome Measure Information:
    Title
    Rey Auditory-Verbal Learning Test
    Description
    The difference in grades of Free And Cued Selective Reminding Test (FCSRT) score between the beginning and the end of the study.
    Time Frame
    up to 5 weeks
    Title
    Free And Cued Selective Reminding Test
    Description
    The difference in grades of Rey Auditory-Verbal Learning Test (RAVLT) score between the beginning and the end of the study.
    Time Frame
    up to 5 weeks
    Title
    Rivermead Behavioral Memory Test
    Description
    The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.
    Time Frame
    up to 5 weeks
    Title
    Clinical Global Impression of Change
    Description
    The difference in grades of Clinical Global Impression of Change (CGI-C) score between the beginning and the end of the study.
    Time Frame
    up to 5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Goded Shahaf, Dr.
    Phone
    97246660676
    Email
    goded@brainmarc.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Dvir, Dr.
    Organizational Affiliation
    Reuth rehabilitation medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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