BestBrain Evaluation of Cognitive Memory & Executive-Function

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Device: iRemember Neurofeedback (NFB)

• Registration Number: NCT03954340
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-12-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 iRemember Treatment	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	iRemember Neurofeedback (NFB)	Subjects randomized to this arm of the study will undergo 20 SHAM treatments

Primary Outcome Measures

Name	Time	Method
Improvement to Executive Functions	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 Memory	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 Every Day Functionality	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)

Trial Locations

Locations (1)

Clalit Health Services; 🇮🇱 Be'er Sheva, Israel