Brain Fitness APP for Cognitive Enhancement
1 other identifier
interventional
30
1 country
1
Brief Summary
Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. While currently there is no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy life style. The proposed research offers a novel approach to prevent dementia and age-related cognitive disorders. We propose to use our developed brain fitness APP for the aging population with dementia. The proposed APP is based on the premise of brain plasticity, and targets the brain functions that are declining with normal aging and dementia. In a pilot study, we showed very positive effects of our custom designed brain exercises to strengthen left-right side brain connectivity in older adults when used regularly. Leveraging our previous design, we have developed an end-user product with additional features and enhanced user interface and user experience that will allow it to be used for neuro-cognitive rehabilitation by an individual without supervision The proposed APP will be tested on 30 individuals with cognitive impairment. Additionally, participants can receive an optional electrical stimulation called transcranial alternating current stimulation. This applies an alternating current to a person's brain by two electrodes placed on the scalp. The participants, who choose this option, will receive simultaneous stimulation during the brain exercise tutored sessions. Studies have shown that simultaneous application of the electrical stimulation and cognitive exercises further enhances the cognitive function by boosting the working memory improvement. Thus, this may lead to further improvements from any potential positive effects of the brain exercises. We anticipate the frequent use of the proposed APP will help to slow and even reverse the progression of the cognition decline in individuals with mild cognitive impairment or dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 24, 2021
February 1, 2021
3.5 years
April 11, 2018
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Wechsler Memory Scale (WMS IV)
This assessment has a total of 11 tests, out of which we will use its six primary tests that assess our target brain functions, comprised of 12 subtests (subsections): Logical Memory 1, Verbal Paired Associates 1, Faces 1, Family Pictures 1, Logical Memory 2, Verbal Paired Associates 2, Faces 2, Family Pictures 2, Verbal Paired Associates 2 Recognition, Logical Memory 2 Recognition, Letter-Number Sequencing and Spatial Span. They are classified into 3 major memory indexes: Immediate Memory, General Memory and Working Memory.
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Secondary Outcomes (2)
Change in Egocentric Spatial Orientation
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Study Arms (2)
Brain fitness app
EXPERIMENTALDaily tutored sessions of brain exercises on an iPAD (in-person or remote)
Brain fitness app with tACS
EXPERIMENTALDaily tutored sessions of brain exercises on an iPAD combined with simultaneous transcranial alternating current stimulation (tACS)
Interventions
Daily tutored sessions of brain exercises on an iPAD (in-person or remote)
Daily tutored sessions of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS)
Eligibility Criteria
You may qualify if:
- Age: 20+ years
- Have a score of 7≤ MoCA ≤ 25
- Being diagnosed with either mild cognitive impairment (MCI) or mild/moderate stage of Alzheimer's.
- Except the MCI/Alzheimer's diagnosis, have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, Huntington disease, ALS, MS, and/or any other neurological disorder.
- Reading/writing fluency in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riverview Health Center
Winnipeg, Manitoba, R3L 2P4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 11, 2018
First Posted
July 16, 2018
Study Start
June 20, 2018
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
February 24, 2021
Record last verified: 2021-02