Longitudinal Study to Investigate Different Transcranial Electrical Stimulation (tES)

November 26, 2025 updated by: Dr. Zahra Kazem-Moussavi, University of Manitoba

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 2P4
        • Recruiting
        • Riverview Health Centre
        • Contact:
        • Contact:
          • Zahra Moussavi
          • Phone Number: 2044786163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
Device: 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.
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wechsler Memory Scale (WMS-IV)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-Back
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
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.
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Neuropsychiatric Inventory Questionnaire (NPIQ)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
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.
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Functional Near Infrared Spectroscopy (fNIRS)
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
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.
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Virtual Reality Navigation (VRN) spatial orientation test
Time Frame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
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).
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2021:089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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