Investigational Dementia Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-12-06

Brief Summary

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This research investigates the effect of active versus sham tACS paired with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a one-time crossing over design in which participants are randomized into two groups: One group will receive active treatment for 4 weeks, then 8 weeks of no treatment followed by another 4 weeks of treatment but with sham. The other group will start with sham and end up with active treatment. The study is double-blind; thus, neither participants, nor the assessors know the group assignment.

The Intervention is applying tACS either active or sham paired with cognitive exercises (MindTriggers app games).

Note: The above study will run at both University of Manitoba (U of M) and Aster Gardens residence. However, at Aster Gardens Residence only questionnaire type of assessments will be run, while in U of M, the investigators will have three other major assessments as well. In addition, the investigators will run the assessments at the Aster Gardens Residence through online sessions.

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Detailed Description

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This research will investigate the effect of applying transcranial alternating current stimulation (tACS) when paired with cognitive exercises on older adults in a placebo-controlled double-blind study with statistical rigor. In addition, the investigators will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention but also to predict the response of a participant to the intervention at baseline. Since most technological intervention on dementia have a demanding and costly protocol, it would be of great interest to have a reliable prediction of a participant to a treatment at baseline; that would lead to personalized optimum treatment strategy. The investigators will use Electrovestibulography (EVestG), Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring and predicting technologies. EVestG is a non-invasive measure of the vestibuloacoustic system in both background (no motion) and in response to passive whole-body tilt stimuli. The investigators hypothesize there is a direct link between vestibular system deficiencies and Alzheimer's. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize it is deteriorated significantly in Alzheimer's even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.

Conditions

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Dementia, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This human research study is a crossover, placebo controlled and double-blind study. It will have two groups of subjects matched in age, and sex and cognitive level (measured by Montreal Cognitive Assessment: MoCA).

Group 1 (G1) participants will receive active tACS simultaneously with cognitive exercises.

Group 2 (G2) participants will receive sham tACS simultaneously with cognitive exercises.

The volunteers who cannot tolerate application of tACS and focus on the cognitive exercises at the same time, will be enrolled in a third group (G3); they will receive only cognitive exercises with the same protocol as in G1 and G2.

We will use only two periods design (one time crossing over).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The group assignment is known only by the study coordinator and the PI. Group assignment will be randomized into either Group 1 or Group 2 using PROC PLAN procedure of SAS randomization. The group assignment of a participant could potentially be unblinded on compassionate ground (e.g., if a participant comes from a different city for the duration of the study) or request of the participant or any emergency situation (although very rare). In that case the participant's data may be excluded from the analysis totally or depending on when this unblinding occur, half of the data might be usable for analysis (if unblinding occur during the waiting period before crossing over). The unblinding decision will be made by the PI.

Study Groups

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Group 1 (G1)

Participants will receive active tACS simultaneously with cognitive exercises.

Group Type EXPERIMENTAL

transcranial alternative current stimulation (tACS)

Intervention Type DEVICE

A light electrical current will be applied to the scalp of the participants via 2 electrodes, while the participants performs cognitive exercises with the guidance of a trained research assistant.

cognitive exercises

Intervention Type OTHER

Participant will perform memory and learning games/tasks through "Mind Triggers" app on an IPad. Participants will be guided by a highly trained research assistant.

Group 2 (G2)

Participants will receive sham tACS simultaneously with cognitive exercises.

Group Type SHAM_COMPARATOR

cognitive exercises

Intervention Type OTHER

Participant will perform memory and learning games/tasks through "Mind Triggers" app on an IPad. Participants will be guided by a highly trained research assistant.

Interventions

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transcranial alternative current stimulation (tACS)

A light electrical current will be applied to the scalp of the participants via 2 electrodes, while the participants performs cognitive exercises with the guidance of a trained research assistant.

Intervention Type DEVICE

cognitive exercises

Participant will perform memory and learning games/tasks through "Mind Triggers" app on an IPad. Participants will be guided by a highly trained research assistant.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ability to read, write and speak English fluently

Exclusion Criteria

* Being diagnosed with Parkinson's, Parkinsonian dementia, Huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder
* Having a History of epileptic seizures or epilepsy
* Inability to adequately communicate in English
* Impaired vision or hearing severe enough to impair performance in cognitive tests
* Current substance abuse disorder
* Currently participating in another therapeutic study for dementia
* Plan to change the medication during this study's period

Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No