Longitudinal Study to Investigate Different Transcranial Electrical Stimulation
tES
1 other identifier
interventional
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2024
CompletedFirst Submitted
Initial submission to the registry
March 10, 2025
CompletedFirst Posted
Study publicly available on registry
March 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
December 4, 2025
March 1, 2025
6.2 years
March 10, 2025
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
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.
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Secondary Outcomes (4)
N-Back
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Neuropsychiatric Inventory Questionnaire (NPIQ)
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Functional Near Infrared Spectroscopy (fNIRS)
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Virtual Reality Navigation (VRN) spatial orientation test
For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- ability to read, write and speak English fluently
- MoCA score between 5 and 24
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Dept. of Electrical and Computer Eng.
Study Record Dates
First Submitted
March 10, 2025
First Posted
March 14, 2025
Study Start
October 9, 2024
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2033
Last Updated
December 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share