Condition or disease | Intervention/treatment | Phase |
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Mild Cognitive Impairment | Device: iRemember Neurofeedback (NFB) | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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
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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
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Sham Comparator: 2 Sham Treatment
Subjects randomized to this arm of the study will undergo 20 SHAM treatments
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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
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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 |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Clalit Health Services | |
Be'er Sheva, Israel |
Tracking Information | |||||||
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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 |
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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. |
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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
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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
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |