Clinical trial NCT05203523: Investigational Dementia Treatment Study
Official title: Investigating the Effect of Cognitive Training with and Without Transcranial Alternating Current Stimulation on the Executive Brain Functions in Dementia Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Riverview Health Centre Foundation
name: Charis Senior Residences LP. DBA Aster Gardens
First posted: 2022-01-24
Enrollment: 73
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.
timeFrame: Baseline (week 0), week 5, week 11, week 16
Secondary outcomes:
measure: N-back test
timeFrame: Baseline (week 0), week 5, week 11, week 16
measure: Neuropsychiatric Inventory Questionnaire (NPIQ)
timeFrame: Baseline (week 0), week 5, week 11, week 16
measure: Functional Near Infrared Spectroscopy (fNIRS)
timeFrame: Baseline (week 0), week 5, week 11, week 16
measure: Electrovestibulography (EVestG)
timeFrame: Baseline (week 0), week 5, week 11, week 16
measure: Virtual Reality Navigation (VRN) spatial orientation test
timeFrame: Baseline (week 0), week 5, week 11, week 16
measure: Speech analysis
timeFrame: Baseline (week 0), week 5, week 11, week 16
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Aster Gardens
state: Alberta
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
Study officials:
References:
citation: Jacobson N, Lithgow B, Jafari Jozani M, Moussavi Z. The Effect of Transcranial Alternating Current Stimulation With Cognitive Training on Executive Brain Function in Individuals With Dementia: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 27;11(4):e37282. doi: 10.2196/37282.