Mild Cognitive ImpairmentBECOMENCT03954340
BestBrain Evaluation of Cognitive Memory & Executive-Function
A study testing iRemember Neurofeedback (NFB) in people with Mild Cognitive Impairment, run by BestBrain Ltd. at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- iRemember Neurofeedback (NFB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Dec 2019to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)
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
Read the 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
- Being tested
- iRemember Neurofeedback (NFB)
- Keywords
- MCI, Early AD
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRemember Neurofeedback (NFB)Device
Also called EEG 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 iRemember Treatment | Active comparator | Subjects randomized to this arm of the study will undergo 20 EEG NFB treatments with the iRemember System for the treatment of MCI Receives: Device: iRemember Neurofeedback (NFB) |
| 2 Sham Treatment | Sham comparator | Subjects randomized to this arm of the study will undergo 20 SHAM treatments Receives: Device: iRemember Neurofeedback (NFB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3-4 months
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)
Measured: 3-4 months
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)
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start11 Dec 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BestBrain Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954340
- Sponsor's protocol ID
- CIP001
- Acronym
- BECOME
- Status last verified
- Oct 2020
- First submitted
- 14 May 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)
- ClinicalTrials.gov ID
- NCT03954340
- Acronym / sponsor ID
- BECOME / CIP001
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, Early AD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- BestBrain Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment
| Arm | Type | Receives |
|---|---|---|
| 1 iRemember Treatment | Active comparator | Device: iRemember Neurofeedback (NFB)Subjects randomized to this arm of the study will undergo 20 EEG NFB treatments with the iRemember System for the treatment of MCI |
| 2 Sham Treatment | Sham comparator | Device: iRemember Neurofeedback (NFB)Subjects randomized to this arm of the study will undergo 20 SHAM treatments |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iRemember Neurofeedback (NFB)Also: EEG NFBNeurofeedback (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. | Device | 1 iRemember Treatment, 2 Sham Treatment |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRemember Neurofeedback (NFB) in people with Mild Cognitive Impairment, run by BestBrain Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement to Memory (time frame: 3-4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.