Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03954340
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
BestBrain Ltd.

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.


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)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954340


Contacts
Layout table for location contacts
Contact: Boris Punchik - PI, MD Phd +97286241222 borispu@clalit.org.il
Contact: Paul Nurflus

Sponsors and Collaborators
BestBrain Ltd.

Layout table for additonal information
Responsible Party: BestBrain Ltd.
ClinicalTrials.gov Identifier: NCT03954340     History of Changes
Other Study ID Numbers: CIP001
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by BestBrain Ltd.:
MCI
Early AD

Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders