BestBrain Evaluation of Cognitive Memory & Executive-Function

NCT ID: NCT03954340

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2021-06-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 iRemember Treatment

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

Group Type: ACTIVE_COMPARATOR

iRemember Neurofeedback (NFB)

Intervention Type: DEVICE

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.

2 Sham Treatment

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

Group Type: SHAM_COMPARATOR

iRemember Neurofeedback (NFB)

Intervention Type: DEVICE

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.

Interventions

iRemember Neurofeedback (NFB)

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.

Intervention Type: DEVICE

Other Intervention Names

EEG NFB

Eligibility Criteria

Inclusion Criteria

1. Male or female age 50-80 years

2. Subjects diagnosed with MCI, according to the ICD-10 criteria.

3. MoCA score 18 to 25

4. Ability to operate a computer mouse and keyboard as evaluated by the clinician.

5. Agreement to participate in approximately 12 weeks during the study.

6. Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).

7. Fluent in Hebrew

8. Willing to participate twice a week for treatments

Exclusion Criteria

1. Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment

2. 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)

3. 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

4. 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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BestBrain Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clalit Health Services

Beersheba, , Israel

Countries

Israel

Other Identifiers

CIP001

Identifier Type: -

Identifier Source: org_study_id