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Brain Fitness APP for Cognitive Enhancement

Primary Purpose

Mild Cognitive Impairment, Alzheimer Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brain fitness app
Brain fitness app with tACS
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riverview Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Brain fitness app

Brain fitness app with tACS

Arm Description

Daily tutored sessions of brain exercises on an iPAD (in-person or remote)

Daily tutored sessions of brain exercises on an iPAD combined with simultaneous transcranial alternating current stimulation (tACS)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Egocentric Spatial Orientation
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).
Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
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.

Full Information

First Posted
April 11, 2018
Last Updated
February 22, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03587012
Brief Title
Brain Fitness APP for Cognitive Enhancement
Official Title
Brain Fitness APP for Cognitive Enhancement of People With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain fitness app
Arm Type
Experimental
Arm Description
Daily tutored sessions of brain exercises on an iPAD (in-person or remote)
Arm Title
Brain fitness app with tACS
Arm Type
Experimental
Arm Description
Daily tutored sessions of brain exercises on an iPAD combined with simultaneous transcranial alternating current stimulation (tACS)
Intervention Type
Other
Intervention Name(s)
Brain fitness app
Intervention Description
Daily tutored sessions of brain exercises on an iPAD (in-person or remote)
Intervention Type
Other
Intervention Name(s)
Brain fitness app with tACS
Intervention Description
Daily tutored sessions of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS)
Primary Outcome Measure Information:
Title
Change in Wechsler Memory Scale (WMS IV)
Description
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.
Time Frame
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Secondary Outcome Measure Information:
Title
Change in Egocentric Spatial Orientation
Description
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).
Time Frame
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Title
Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
Description
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.
Time Frame
baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Francisco, Ph.D.
Phone
204-478-6163
Email
cristina.francisco@umanitoba.ca
Facility Information:
Facility Name
Riverview Health Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Francisco, Ph.D.
Phone
204-478-6163
Email
Cristina.Francisco@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Zahra Moussavi, Ph.D.
Phone
204-478-6163
Email
Zahra.Moussavi@Umanitoba.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Brain Fitness APP for Cognitive Enhancement

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