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BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

iRemember Neurofeedback (NFB)

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring MCI, Early AD

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female age 50-80 years
Subjects diagnosed with MCI, according to the ICD-10 criteria.
MoCA score 18 to 25
Ability to operate a computer mouse and keyboard as evaluated by the clinician.
Agreement to participate in approximately 12 weeks during the study.
Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
Fluent in Hebrew
Willing to participate twice a week for treatments

Exclusion Criteria:

Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment
Subjects with one or more of the following disorders in their medical files: psychotic disorder, currently active depression, with a history of bipolar disorder, adjustment disorder, somataform disorder, anxiety disorder OCD, PTSD. (following the Axis-1 disorders listed in the ICD-10)
Alcoholism or drug addiction as defined by ICD-10 within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
Subjects with personal history of a clinically defined neurological/psychiatric disorder including (but not limited to): epilepsy, dementia, clinical stroke (hemiparesis, hemianopsia) , substance abuse, extra pyramidal disorders like parkinson etc) , major head trauma, multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness; use of any medication with the aim to improve cognition (cholinesterase inhibitors).

Sites / Locations

Clalit Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1 iRemember Treatment

2 Sham Treatment

Arm Description

Subjects randomized to this arm of the study will undergo 20 EEG NFB treatments with the iRemember System for the treatment of MCI

Subjects randomized to this arm of the study will undergo 20 SHAM treatments

Outcomes

Primary Outcome Measures

Improvement to Memory

Improvement in memory based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Improvement to Executive Functions

Improvement to Executive Functions based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Improvement to Every Day Functionality

Improvement Every Day Functionality based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Secondary Outcome Measures

Full Information

NCT ID

NCT03954340

First Posted

May 14, 2019

Last Updated

October 21, 2020

Sponsor

BestBrain Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03954340

Brief Title

BestBrain Evaluation of Cognitive Memory & Executive-Function

Acronym

BECOME

Official Title

BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 11, 2019 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BestBrain Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study is intended 1. To quantify the effects of the iRemember personalized EEG-NFB therapy on working memory and executive functions in subjects with MCI by calculating the percentage of change in the Neurotrax tests performed prior to and after the treatment, and compare the results between the active treatment and placebo cohorts

Detailed Description

By using the BestBrain iRemember EEG-NFB System, subjects within the "treatment" arm of this clinical investigation will show improvement in working memory, executive functions and general improvement in daily life based on standard accepted cognitive tests such as the Neurotrax and Kielhfner questionnaire. This hypothesis will be accepted or rejected based on the statistical analysis of the data collected . Subjects will be randomized either to the treatment or placebo groups. Each subject will undergo an initial and final assessment using NeuroTrax and specified questionnaires prior to and after 20 treatments. The first sessions will be dedicated to subject evaluation. Each subject will undergo either a neurofeedback (NFB) or sham treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

MCI, Early AD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment

Masking

ParticipantCare ProviderInvestigator

Masking Description

all will be blinded to sham or treatment

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1 iRemember Treatment

Arm Type

Active Comparator

Arm Description

Subjects randomized to this arm of the study will undergo 20 EEG NFB treatments with the iRemember System for the treatment of MCI

Arm Title

2 Sham Treatment

Arm Type

Sham Comparator

Arm Description

Subjects randomized to this arm of the study will undergo 20 SHAM treatments

Intervention Type

Device

Intervention Name(s)

iRemember Neurofeedback (NFB)

Other Intervention Name(s)

EEG NFB

Intervention Description

Neurofeedback (NFB) is a treatment technique based on learning with operant conditioning, in which a feedback (or a reward) is given in proportion with the desired physiological activity in order to improve cognition and/or behavior. This research will focus on EEG-NF where electrical activity measured with EEG serves as the physiological activity to be influenced. EEG-NFB has been successfully used as a clinical tool for over 40 years treating various disorders from Autism , ADHD , Epilepsy , OCD and depression Electroencephalography (EEG) equipment is used to measure the electrical activity representing the neuronal activity of different parts of the brain. During the treatment, electrode(s) are placed in predetermined location. Audio and visual rewards are given when the activity is measured to be within the desired frequency range.

Primary Outcome Measure Information:

Title

Improvement to Memory

Description

Improvement in memory based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Time Frame

3-4 months

Title

Improvement to Executive Functions

Description

Improvement to Executive Functions based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Time Frame

3-4 months

Title

Improvement to Every Day Functionality

Description

Improvement Every Day Functionality based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

Time Frame

3-4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female age 50-80 years Subjects diagnosed with MCI, according to the ICD-10 criteria. MoCA score 18 to 25 Ability to operate a computer mouse and keyboard as evaluated by the clinician. Agreement to participate in approximately 12 weeks during the study. Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid). Fluent in Hebrew Willing to participate twice a week for treatments Exclusion Criteria: Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment Subjects with one or more of the following disorders in their medical files: psychotic disorder, currently active depression, with a history of bipolar disorder, adjustment disorder, somataform disorder, anxiety disorder OCD, PTSD. (following the Axis-1 disorders listed in the ICD-10) Alcoholism or drug addiction as defined by ICD-10 within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation Subjects with personal history of a clinically defined neurological/psychiatric disorder including (but not limited to): epilepsy, dementia, clinical stroke (hemiparesis, hemianopsia) , substance abuse, extra pyramidal disorders like parkinson etc) , major head trauma, multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness; use of any medication with the aim to improve cognition (cholinesterase inhibitors).

Facility Information:

Facility Name

Clalit Health Services

City

Be'er Sheva

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

BestBrain Evaluation of Cognitive Memory & Executive-Function

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