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Dementia, MildtACSNCT05203523

Investigational Dementia Treatment Study

A study testing transcranial alternative current stimulation (tACS) and cognitive exercises in people with Dementia, Mild, run by University of Manitoba at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Dementia, Mild
What is being tested?
transcranial alternative current stimulation (tACS) and cognitive exercises
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
2 sitesCanada
Study dates
24 Jan 2022to 6 Dec 2024
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 50 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ability to read, write and speak English fluently

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Aster Gardens

    Edmonton, Alberta

  • Riverview Health Centre

    Winnipeg, Manitoba, R3L 2P4

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Dementia, Mild
Being tested
transcranial alternative current stimulation (tACS), cognitive exercises
Medical subject headings
Dementia, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial alternative current stimulation (tACS)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 exercisesOther

    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.

Study groups in NCT05203523
Study groupRoleWhat they receive
Group 1 (G1)ExperimentalParticipants will receive active tACS simultaneously with cognitive exercises.
Receives: Device: transcranial alternative current stimulation (tACS); Other: cognitive exercises
Group 2 (G2)Sham comparatorParticipants will receive sham tACS simultaneously with cognitive exercises.
Receives: Other: cognitive exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline (week 0), week 5, week 11, week 16

Secondary outcomes (6)

  1. N-back test

    N is a number between 1 and 4. A sequence of random shapes is presented and the participant has to tap or say if (remember) whether a presented object is a repeat of the Nth previous object. We will use this test with N=1 as for N>1 is very challenging for dementia population to perform.

    Measured: Baseline (week 0), week 5, week 11, week 16

  2. Neuropsychiatric Inventory Questionnaire (NPIQ)

    Questionnaire used to assesses neuropsychiatric symptoms and caregiver burden The score of the NPIQ is based on the presence of a specified symptom and a separate score for severity of the symptom. For presence the minimum total score is 0, maximum score is 12. For severity the minimum total score is 0, maximum is 36. Higher scores indicate the participant is exhibiting more severe changes in behaviors.

    Measured: Baseline (week 0), week 5, week 11, week 16

  3. Functional Near Infrared Spectroscopy (fNIRS)

    fNIRS is a device designed mainly for measuring the blood flow over the prefrontal cortex. Participants will perform a verbal fluency task while the fNIRS measures signals simultaneously.

    Measured: Baseline (week 0), week 5, week 11, week 16

  4. Electrovestibulography (EVestG)

    EVestG is explored as a monitoring and predictive tool for treatment efficacy, starting at baseline. If participant's ears are free of wax, blood, scarring, then they will be eligible for electrode placement and EVestG recording.

    Measured: Baseline (week 0), week 5, week 11, week 16

  5. Virtual Reality Navigation (VRN) spatial orientation test

    The VRN test will be run in non-immersive mode using a large screen and joystick in the PI's office at Riverview Health Center by one of the VRN team member (a research assistant). This program runs only on PC. Run the "rummeego.bat" file in the folder VRN V5 to run the program. Press "s" button to rotate the building. Pressing "Esc" exits that trial and goes to next.

    The VRN has two stages: 1) Localization, 2) Navigation. The second stage will be carried out only if a participant can pass the localization stage with a score >15 (basically with no consistent side error).

    Measured: Baseline (week 0), week 5, week 11, week 16

  6. Speech analysis

    During WMS-IV assessment, participants are interviewed with a chit-chat about their daily life and events. For speech assessment, we use the first few minutes of that interview as well as the spoken parts of the WMS-IV assessment, where the participant has to recall a story, will be recorded and used. This assessment is basically signal (speech) processing of the recorded audio at each assessment time and find features that could be representative of a change due to treatment.

    Measured: Baseline (week 0), week 5, week 11, week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start24 Jan 2022
  3. Primary completion6 Dec 2024
  4. Study completion6 Dec 2024

Resources

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
Randomised
Intervention model
Crossover
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).
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203523
Sponsor's protocol ID
HS25171(B2021:089)
Acronym
tACS
Status last verified
Feb 2022
First submitted
3 Oct 2021
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35475789

Questions about this trial

What is this clinical trial studying?

A study testing transcranial alternative current stimulation (tACS) and cognitive exercises in people with Dementia, Mild, run by University of Manitoba at 2 sites 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203523, which also lists 1 linked publication.

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 13 Mar 2025.

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