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Clinical Trials/NCT03375151
NCT03375151
Unknown
N/A

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

Brainmarc Ltd.0 sites60 target enrollmentFebruary 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Brainmarc Ltd.
Enrollment
60
Primary Endpoint
Cognitive test grade
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2018
End Date
April 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Cognitive test grade

Time Frame: up to 5 weeks

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 Outcomes

  • Rey Auditory-Verbal Learning Test(up to 5 weeks)
  • Clinical Global Impression of Change(up to 5 weeks)
  • Rivermead Behavioral Memory Test(up to 5 weeks)
  • Free And Cued Selective Reminding Test(up to 5 weeks)

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