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Dementia; Degenerative, Dementia MixedtESNCT06877312

Longitudinal Study to Investigate Different Transcranial Electrical Stimulation

A study testing Transcranial Direct Current Stimulation (tDCS), 30 Hz Transcranial Alternating Current Stimulation (tACS) and 50 Hz Transcranial Alternating Current Stimulation (tACS) in people with Dementia; Degenerative, Dementia Mixed, run by University of Manitoba at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of 4 weeks, everyday (Monday to Friday). The study design is a longitudinal study design in which participants receive different tES randomly ordered. Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Dementia; Degenerative, Dementia Mixed
What is being tested?
Transcranial Direct Current Stimulation (tDCS), 30 Hz Transcranial Alternating Current Stimulation (tACS) and 50 Hz Transcranial Alternating Current Stimulation (tACS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
9 Oct 2024to 31 Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • MoCA score between 5 and 24

Who cannot join

  • Being diagnosed with Parkinson's disease, 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 any treatment period (5 weeks including the pre-post assessments)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Riverview Health Centre

    Winnipeg, Manitoba, R3L 2P4

    Shelly Rempel-Rossum, 204-789-3389, Shelly.rempel-rossum@umanitoba.ca

    Zahra Moussavi, 2044786163

    Recruiting

Other trials in Canada

About this study

Official title: Longitudinal Study to Investigate Different Treatment Protocols of Transcranial Electrical Stimulation for Individuals With Dementia

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of 4 weeks, everyday (Monday to Friday). The study design is a longitudinal study design in which participants receive different tES randomly ordered. Treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tES treatment type. Participants have the option of having their choice of music in the background while they perform cognitive exercises.

Read the detailed description

This research will investigate the effect of applying transcranial electrical stimulation (tES) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. In addition, the researchers will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. Since most technological interventions on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. The investigators will use Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring technologies. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize that it is deteriorated significantly in Alzheimer's disease 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.

Being tested
Transcranial Direct Current Stimulation (tDCS), 30 Hz Transcranial Alternating Current Stimulation (tACS), 50 Hz Transcranial Alternating Current Stimulation (tACS), 70 Hz Transcranial Alternating Current Stimulation (tACS), 90 Hz Transcranial Alternating Current Stimulation (tACS)
Keywords
dementia, alzheimer, cognitive impairment
Medical subject headings
Dementia, Mixed Dementias, Cognitive Dysfunction

What participants receive

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

  • Transcranial Direct Current Stimulation (tDCS)Device

    A light electrical current with zero frequency (tDCS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

    Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Participants will be guided by a highly trained research assistant.

  • 30 Hz Transcranial Alternating Current Stimulation (tACS)Device

    A light electrical current with 30 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

    Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Participants will be guided by a highly trained research assistant.

  • 50 Hz Transcranial Alternating Current Stimulation (tACS)Device

    A light electrical current with 50 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

    Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Participants will be guided by a highly trained research assistant.

  • 70 Hz Transcranial Alternating Current Stimulation (tACS)Device

    A light electrical current with 70 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

    Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Participants will be guided by a highly trained research assistant.

  • 90 Hz Transcranial Alternating Current Stimulation (tACS)Device

    A light electrical current with 90 Hz frequency (tACS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

    Cognitive exercises: Participants will perform memory and learning games/tasks through the "Mind Triggers" app on an IPad and other cognitive games. Participants will be guided by a highly trained research assistant.

  • Transcranial Random Noise Stimulation (tRNS)Device

    A light electrical current with random noise waveform (tRNS) will be applied to the scalp of the participants via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. They have the option of having their choice of music playing in the background while they perform the cognitive exercises.

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

Study groups in NCT06877312
Study groupRoleWhat they receive
Transcranial Direct Current Stimulation (tDCS)ExperimentalParticipants will receive active tDCS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: Transcranial Direct Current Stimulation (tDCS)
30 Hz Transcranial Alternating Current Stimulation (tACS)ExperimentalParticipants will receive active tACS at 30 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: 30 Hz Transcranial Alternating Current Stimulation (tACS)
50 Hz Transcranial Alternating Current Stimulation (tACS)ExperimentalParticipants will receive active tACS at 50 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: 50 Hz Transcranial Alternating Current Stimulation (tACS)
70 Hz Transcranial Alternating Current Stimulation (tACS)ExperimentalParticipants will receive active tACS at 70 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: 70 Hz Transcranial Alternating Current Stimulation (tACS)
90 Hz Transcranial Alternating Current Stimulation (tACS)ExperimentalParticipants will receive active tACS at 90 Hz simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: 90 Hz Transcranial Alternating Current Stimulation (tACS)
Transcranial Random Noise Stimulation (tRNS)ExperimentalParticipants will receive active tRNS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.
Receives: Device: Transcranial Random Noise Stimulation (tRNS)

What is being measured

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

  1. Alzheimer's Disease Assessment Scale (ADAS-Cog)

    Change from baseline ADAS-Cog at 5 and 9 weeks. It consists of 11 tasks that include the subject completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis.

    Measured: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

  2. Wechsler Memory Scale (WMS-IV)

    Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five and nine 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: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

Secondary outcomes (4)
  1. N-Back

    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: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

  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: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

  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: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

  4. 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: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

Timeline

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

  1. First posted14 Mar 2025
  2. Study start9 Oct 2024
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2033 (estimated)

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
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877312
Sponsor's protocol ID
B2021:089
Acronym
tES
Status last verified
Mar 2025
First submitted
10 Mar 2025
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation (tDCS), 30 Hz Transcranial Alternating Current Stimulation (tACS) and 50 Hz Transcranial Alternating Current Stimulation (tACS) in people with Dementia; Degenerative, Dementia Mixed, run by University of Manitoba at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Shelly Rempel-Rossum (204-789-3389, Shelly.rempelrossum@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale (ADAS-Cog) (time frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Dec 2025.

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