Recruiting

Brain Fitness APP

Sponsor:

University of Manitoba

Code:

NCT03587012

Conditions

Mild Cognitive Impairment

Alzheimer Dementia

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Brain fitness app

Brain fitness app with tACS

Study Details

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.

Conditions

Mild Cognitive Impairment

Alzheimer Dementia

Study ID

NCT03587012

Start date

Jun 20, 2018

Status verified date

Feb, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brain fitness app

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

experimental: Brain fitness app with tACS

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

Interventions

Brain fitness app

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

Brain fitness app with tACS

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

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 ]

Central Contacts and Locations

Central contacts

Cristina Francisco, Ph.D.

204-478-6163cristina.francisco@umanitoba.ca

Locations

Riverview Health Center

Recruiting

Winnipeg, Manitoba, Canada, R3L 2P4

Contacts

Cristina Francisco, Ph.D.

204-478-6163Cristina.Francisco@umanitoba.ca

Zahra Moussavi, Ph.D.

204-478-6163Zahra.Moussavi@Umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Feb 24, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2021-02-24.