Mild Cognitive ImpairmentNCT03587012
Brain Fitness APP for Cognitive Enhancement
A study testing Brain fitness app and Brain fitness app with tACS in people with Mild Cognitive Impairment and Alzheimer Dementia, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Dementia
- What is being tested?
- Brain fitness app and Brain fitness app with tACS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Riverview Health Center
Winnipeg, Manitoba, R3L 2P4
Cristina Francisco, Ph.D., 204-478-6163, Cristina.Francisco@umanitoba.ca
Zahra Moussavi, Ph.D., 204-478-6163, Zahra.Moussavi@Umanitoba.ca
About this study
Official title: Brain Fitness APP for Cognitive Enhancement of People With Dementia
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.
Read more
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.
Read the 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:
- 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).
- Conditions
- Mild Cognitive Impairment, Alzheimer Dementia
- Being tested
- Brain fitness app, Brain fitness app with tACS
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain fitness appOther
Daily tutored sessions of brain exercises on an iPAD (in-person or remote)
Brain fitness app with tACSOther
Daily tutored sessions of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS)
| Study group | Role | What they receive |
|---|---|---|
| Brain fitness app | Experimental | Daily tutored sessions of brain exercises on an iPAD (in-person or remote) Receives: Other: Brain fitness app |
| Brain fitness app with tACS | Experimental | Daily tutored sessions of brain exercises on an iPAD combined with simultaneous transcranial alternating current stimulation (tACS) Receives: Other: Brain fitness app with tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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)
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.
Measured: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start20 Jun 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zahra Kazem-Moussavi, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587012
- Sponsor's protocol ID
- B2018:029GB
- Status last verified
- Feb 2021
- First submitted
- 11 Apr 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Fitness APP for Cognitive Enhancement of People With Dementia
- ClinicalTrials.gov ID
- NCT03587012
- Acronym / sponsor ID
- B2018:029GB
- Conditions
- Mild Cognitive Impairment, Alzheimer Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain fitness app | Experimental | Other: Brain fitness appDaily tutored sessions of brain exercises on an iPAD (in-person or remote) |
| Brain fitness app with tACS | Experimental | Other: Brain fitness app with tACSDaily tutored sessions of brain exercises on an iPAD combined with simultaneous transcranial alternating current stimulation (tACS) |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain fitness appDaily tutored sessions of brain exercises on an iPAD (in-person or remote) | Other | Brain fitness app |
| Brain fitness app with tACSDaily tutored sessions of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS) | Other | Brain fitness app with tACS |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain fitness app and Brain fitness app with tACS in people with Mild Cognitive Impairment and Alzheimer Dementia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Francisco, Ph.D. (204-478-6163, cristina.francisco@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.