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

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ClinicalTrials.gov Identifier: NCT03375151
Recruitment Status : Not yet recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Brainmarc Ltd.

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: EEG based feedback Behavioral: Standard practice based feedback Behavioral: No feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: EEG based feedback
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.
Device: EEG based feedback
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.

Behavioral: Standard practice based feedback
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.

Standard practice based feedback
The therapist will give feedback to the participants during the exercise based on their performance.
Behavioral: Standard practice based feedback
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.

No feedback
The participants will perform the exercise without feedback during practice.
Behavioral: No feedback
Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rey Auditory-Verbal Learning Test [ Time Frame: up to 5 weeks ]
    The difference in grades of Free And Cued Selective Reminding Test (FCSRT) score between the beginning and the end of the study.

  2. Free And Cued Selective Reminding Test [ Time Frame: up to 5 weeks ]
    The difference in grades of Rey Auditory-Verbal Learning Test (RAVLT) score between the beginning and the end of the study.

  3. Rivermead Behavioral Memory Test [ Time Frame: up to 5 weeks ]
    The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.

  4. Clinical Global Impression of Change [ Time Frame: up to 5 weeks ]
    The difference in grades of Clinical Global Impression of Change (CGI-C) score between the beginning and the end of the study.



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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375151


Contacts
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Contact: Goded Shahaf, Dr. 97246660676 goded@brainmarc.com

Sponsors and Collaborators
Brainmarc Ltd.
Investigators
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Principal Investigator: David Dvir, Dr. Reuth rehabilitation medical center

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Responsible Party: Brainmarc Ltd.
ClinicalTrials.gov Identifier: NCT03375151     History of Changes
Other Study ID Numbers: CLD13
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders