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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03375151
Enrollment
60
Registered
2017-12-15
Start date
2018-02-28
Completion date
2019-04-30
Last updated
2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

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.

Interventions

DEVICEEEG 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.

BEHAVIORALStandard 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.

BEHAVIORALNo feedback

Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.

Sponsors

Brainmarc Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive test gradeup to 5 weeksThe difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.

Secondary

MeasureTime frameDescription
Rey Auditory-Verbal Learning Testup to 5 weeksThe 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 Testup to 5 weeksThe difference in grades of Rey Auditory-Verbal Learning Test (RAVLT) score between the beginning and the end of the study.
Rivermead Behavioral Memory Testup to 5 weeksThe difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.
Clinical Global Impression of Changeup to 5 weeksThe difference in grades of Clinical Global Impression of Change (CGI-C) score between the beginning and the end of the study.

Contacts

Primary ContactGoded Shahaf, Dr.
goded@brainmarc.com97246660676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026