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Clinical Trials/NCT05203523
NCT05203523
Completed
Not Applicable

Investigating the Effect of Cognitive Training with and Without Transcranial Alternating Current Stimulation on the Executive Brain Functions in Dementia Population

University of Manitoba2 sites in 1 country73 target enrollmentJanuary 24, 2022
ConditionsDementia, Mild

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia, Mild
Sponsor
University of Manitoba
Enrollment
73
Locations
2
Primary Endpoint
Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2022
End Date
December 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Zahra Kazem-Moussavi

Professor, Dept. of Electrical and Computer Eng. Director Biomedical Engineering

University of Manitoba

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

Outcomes

Primary Outcomes

Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five, eleven and sixteen weeks.

Time Frame: Baseline (week 0), week 5, week 11, week 16

Cognitive and memory task that focus on 6 major memory indexes: Auditory Memory, Visual Memory, Visual Working Memory, Immediate Memory, Delayed Memory, and Recognition Memory.

Secondary Outcomes

  • N-back test(Baseline (week 0), week 5, week 11, week 16)
  • Functional Near Infrared Spectroscopy (fNIRS)(Baseline (week 0), week 5, week 11, week 16)
  • Electrovestibulography (EVestG)(Baseline (week 0), week 5, week 11, week 16)
  • Virtual Reality Navigation (VRN) spatial orientation test(Baseline (week 0), week 5, week 11, week 16)
  • Neuropsychiatric Inventory Questionnaire (NPIQ)(Baseline (week 0), week 5, week 11, week 16)
  • Speech analysis(Baseline (week 0), week 5, week 11, week 16)

Study Sites (2)

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