Longitudinal Study to Investigate Different Transcranial Electrical Stimulation

NCT ID: NCT06877312

Last Updated: 2025-12-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia; Degenerative, Dementia Mixed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial Direct Current Stimulation (tDCS)

Participants will receive active tDCS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type 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)

Participants 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.

Group Type EXPERIMENTAL

30 Hz Transcranial Alternating Current Stimulation (tACS)

Intervention Type 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)

Participants 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.

Group Type EXPERIMENTAL

50 Hz Transcranial Alternating Current Stimulation (tACS)

Intervention Type 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)

Participants 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.

Group Type EXPERIMENTAL

70 Hz Transcranial Alternating Current Stimulation (tACS)

Intervention Type 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)

Participants 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.

Group Type EXPERIMENTAL

90 Hz Transcranial Alternating Current Stimulation (tACS)

Intervention Type 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)

Participants will receive active tRNS simultaneously with cognitive exercises. It will be optional for participants to have their choice of music playing in the background.

Group Type EXPERIMENTAL

Transcranial Random Noise Stimulation (tRNS)

Intervention Type 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.

Interventions

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50 Hz Transcranial Alternating Current Stimulation (tACS)

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.

Intervention Type DEVICE

70 Hz Transcranial Alternating Current Stimulation (tACS)

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.

Intervention Type DEVICE

90 Hz Transcranial Alternating Current Stimulation (tACS)

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.

Intervention Type DEVICE

Transcranial Random Noise Stimulation (tRNS)

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.

Intervention Type DEVICE

Transcranial Direct Current Stimulation (tDCS)

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.

Intervention Type DEVICE

30 Hz Transcranial Alternating Current Stimulation (tACS)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ability to read, write and speak English fluently
* MoCA score between 5 and 24

Exclusion Criteria

* 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Zahra Kazem-Moussavi

Professor, Dept. of Electrical and Computer Eng.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Riverview Health Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Shelly Rempel-Rossum

Role: CONTACT

204-789-3389

Facility Contacts

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Shelly Rempel-Rossum

Role: primary

204-789-3389

Zahra Moussavi

Role: backup

2044786163

Other Identifiers

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B2021:089

Identifier Type: -

Identifier Source: org_study_id

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