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Clinical Trials/NCT03587012
NCT03587012
Unknown
N/A

Brain Fitness APP for Cognitive Enhancement of People With Dementia

University of Manitoba1 site in 1 country30 target enrollmentJune 20, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University of Manitoba
Enrollment
30
Locations
1
Primary Endpoint
Change in Wechsler Memory Scale (WMS IV)
Last Updated
5 years ago

Overview

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.

Detailed Description

The research is on the frequent use of our designed APP (for iPADs) that contains a series of our recently developed brain exercises that contains a series of our recently developed brain exercises, including orientation, associative memory, word-image association, recall memory, etc. Participant can receive an optional electrical stimulation called transcranial alternating current stimulation (tACS) simultaneously during the brain exercise tutor sessions. Each participant will have a dedicated tutor for Brain Exercises with three scheduling options: A) 5 days/week, 2 sessions/day each 30 min) for a period of 4 weeks, B) 3 days/week, 2 sessions/day each 30 minute for a period of 8 weeks, C) Remote program, 5 days/week, 40min/day for a period of 4 weeks (this option is not available for participants receiving tACS).

Registry
clinicaltrials.gov
Start Date
June 20, 2018
End Date
December 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Zahra Kazem-Moussavi

Professor

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Wechsler Memory Scale (WMS IV)

Time Frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment

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.

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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