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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03375151
• Other study ID #: CLD13
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 13, 2017
• Start date: February 2018
• Est. completion date: April 2019

Study information

• Verified date: December 2017
• Source: Brainmarc Ltd.
• Contact: Goded Shahaf, Dr.
• Phone: 97246660676
• Email: goded[@]brainmarc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• No feedback
Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brainmarc Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 5 weeks
Secondary	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.	up to 5 weeks
Secondary	Rivermead Behavioral Memory Test	The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.	up to 5 weeks
Secondary	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.	up to 5 weeks