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Brain Fitness APP for Cognitive Enhancement

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587012
Recruitment Status : Enrolling by invitation
First Posted : July 16, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Zahra Kazem-Moussavi, University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Dementia Other: Brain fitness app Other: Brain fitness app with tACS Not Applicable

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 simultaneously during the brain exercise tutor sessions.

Each participant will have a dedicated tutor for Brain Exercises with two scheduling options:

A) 5 days/week, 2 sessions/day each 30 min) for a period of 4 weeks, or B) 3 days/week, 2 sessions/day each 30 minute for a period of 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Fitness APP for Cognitive Enhancement of People With Dementia
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Exercising
Practicing with the brain exercises
Other: Brain fitness app
Daily practices of brain exercises on an iPAD

Other: Brain fitness app with tACS
Daily practices of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Egocentric Spatial Orientation [ Time Frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment ]
    This test is one of the PI's designs that has been in use since a few years ago. It is used for detecting the onset of Alzheimer's. In this test participants sit in a customized wheelchair and by waking the wheelchair they move within a virtual cubic building to reach a particular target room. They can do this test either using the laptop screen or in its immersive version wearing a goggle (Oculus Rift 2).

  2. Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS) [ Time Frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment ]
    The MADRS is a ten item rating scale for rating levels of depression. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates absence of the symptom and 6 indicates extreme presence of the symptom. The time frame for the scale is the previous four weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03587012


Locations
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Canada, Manitoba
Riverview Health Center
Winnipeg, Manitoba, Canada, R3L 2P4
Sponsors and Collaborators
University of Manitoba

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Responsible Party: Dr. Zahra Kazem-Moussavi, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT03587012    
Other Study ID Numbers: B2018:029GB
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Tauopathies
Neurodegenerative Diseases