An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedDecember 15, 2017
December 1, 2017
1 year
December 13, 2017
December 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Rey Auditory-Verbal Learning Test
up to 5 weeks
Free And Cued Selective Reminding Test
up to 5 weeks
Rivermead Behavioral Memory Test
up to 5 weeks
Clinical Global Impression of Change
up to 5 weeks
Study Arms (3)
EEG based feedback
EXPERIMENTALThe 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.
Standard practice based feedback
OTHERThe therapist will give feedback to the participants during the exercise based on their performance.
No feedback
OTHERThe participants will perform the exercise without feedback during practice.
Interventions
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.
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.
Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brainmarc Ltd.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Dvir, Dr.
Reuth rehabilitation medical center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 15, 2017
Study Start
February 1, 2018
Primary Completion
February 1, 2019
Study Completion
April 1, 2019
Last Updated
December 15, 2017
Record last verified: 2017-12