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出境医 / 临床实验 / BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)

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

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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: iRemember Neurofeedback (NFB) Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: all will be blinded to sham or treatment
Primary Purpose: Treatment
Official Title: BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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
Device: 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.

Other Name: EEG NFB

Sham Comparator: 2 Sham Treatment
Subjects randomized to this arm of the study will undergo 20 SHAM treatments
Device: 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.

Other Name: EEG NFB

Outcome Measures
Primary Outcome Measures :
  1. Improvement to Memory [ Time Frame: 3-4 months ]
    Improvement in memory based on evaluation before and after treatment with the iRemember EEG NFB System (greater than in subjects who received SHAM treatments)

  2. Improvement to Executive Functions [ Time Frame: 3-4 months ]
    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)

  3. Improvement to Every Day Functionality [ Time Frame: 3-4 months ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Locations
Layout table for location information
Israel
Clalit Health Services
Be'er Sheva, Israel
Sponsors and Collaborators
BestBrain Ltd.
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Improvement to Memory [ Time Frame: 3-4 months ]
    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 [ Time Frame: 3-4 months ]
    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 [ Time Frame: 3-4 months ]
    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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BestBrain Evaluation of Cognitive Memory & Executive-Function
Official Title  ICMJE BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
all will be blinded to sham or treatment
Primary Purpose: Treatment
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE Device: 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.

Other Name: EEG NFB
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Device: iRemember Neurofeedback (NFB)
  • Sham Comparator: 2 Sham Treatment
    Subjects randomized to this arm of the study will undergo 20 SHAM treatments
    Intervention: Device: iRemember Neurofeedback (NFB)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954340
Other Study ID Numbers  ICMJE CIP001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BestBrain Ltd.
Study Sponsor  ICMJE BestBrain Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BestBrain Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP