Clinical trial NCT03954340: BestBrain Evaluation of Cognitive Memory & Executive-Function
Official title: BestBrain Evaluation of Cognitive Memory & Executive-Function (BECOME)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: MCI
Early AD
Lead sponsor: BestBrain Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will undergo either EEG NFB treatment with the iRemember System or a sham treatment
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Improvement to Memory
timeFrame: 3-4 months
measure: Improvement to Executive Functions
timeFrame: 3-4 months
measure: Improvement to Every Day Functionality
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Clalit Health Services
Study officials:
References: