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
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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.
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
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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