DementiaNCT06547021
Investigating Different Frequencies of Transcranial Electrical Stimulations in Dementia Population
A study testing Transcranial Direct Current Stimulation (tDCS), Gamma Transcranial Alternating Current Stimulation (tACS) and Theta Transcranial Alternating Current Stimulation (tACS) in people with Dementia, run by University of Manitoba at 1 site in Canada.
Trial summary
Dementia is a prevalent condition with no known cure. It affects not only the person with dementia but also the family. This study will investigate the effects of applying different transcranial electrical stimulation (tES) waveforms to find the optimal stimulation when paired with cognitive exercise on older adults… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Dementia
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS), Gamma Transcranial Alternating Current Stimulation (tACS) and Theta Transcranial Alternating Current Stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2024to 31 Aug 2027
- 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
- MoCA score between 5 and 24
- Between the age of 50 and 95 years old
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
- Change to medication for Alzheimer's disease, dementia, or depression
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
- Recruiting
Riverview Health Centre
Winnipeg
Moussavi, 204-478-6163, MARITERE.GARCIACAMPUZANO@umanitoba.ca
About this study
Official title: Investigating the Effect of Different Frequencies of Transcranial Electrical Stimulations Paired With Cognitive Training on the Executive Brain Functions in Dementia Population
Dementia is a prevalent condition with no known cure. It affects not only the person with dementia but also the family. This study will investigate the effects of applying different transcranial electrical stimulation (tES) waveforms to find the optimal stimulation when paired with cognitive exercise on older adults with dementia. It is a placebo-controlled double-blind study with statistical rigor. In addition, the investigators will investigate technological methods to monitor changes due to the intervention. These include functional near infrared spectroscopy (fNIRS), electroencephalography (EEG), electrovestibulography (EVestG), and balance measurements using accelerometers. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention. EEG measures the electrical activity of the brain via electrodes placed on the scalp to study the brain's response to different electrical stimulations treatments. EVestG is a non-invasive measure of the vestibuloacoustic system in both background (no motion) and in response to passive whole-body tilt stimuli. We hypothesize there is a direct link between vestibular system deficiencies and Alzheimer's. Lastly, the investigators will measure the effects of electrical stimulation on balance by measuring postural sway using two accelerometers.
This study investigates the effects of transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) with different protocols for frequencies to determine the most effective treatment to improve cognitive abilities and working memory for people with dementia.
Read more
The global objective of the proposed study is to investigate the effects of different tES in improving the cognitive status of older adults with dementia, when paired simultaneously with cognitive training. The general objectives include the following:
- Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
- Investigate the correlation of fNIRS outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on balance for older adults with cognitive impairment.
- Investigate the correlation of EVestG outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictively to the treatment at baseline.
- Disseminate the project results and design the next follow up project.
Read the detailed description
About 100 participants with either mild cognitive impairment (MCI) or a probable early or moderate dementia type excluding Parkinsonian dementia (as confirmed by their treating physician), will be recruited and tested over the course of this study.
Participants will have the option to choose to do the stimulation and cognitive exercise from home or at Riverview Health Centre. However, all assessments will be completed at Riverview Health Centre. One of the main limitations of human research is the small sample size as recruitment and enrollment of eligible participants especially in dementia population is a major challenge. Thus, a longitudinal study. Each participant will receive all 4 tES protocols in a randomized order while playing cognitive exercises:
- Personalized gamma tACS
- Personalized theta tACS
- tDCS (zero frequency)
- Sham tES The protocol for all tES treatments will be 4 weeks, 5 days/week (excluding weekends), two 30-min training sessions/day with 15 to 30 min break in between, all tutored either in-person or virtually. Participants will be assessed the week before each new treatment block, within a week of post-treatment and a month after the end of treatment block (follow-up). Between the different tES treatment protocols, 8-week to 20-week washout period will take place with no treatment. The time period for each participant to receive all 4 protocols will be around one year and a half depending on the duration of the washout period. After the participant completes all 4 protocols, there is one more treatment protocol where the participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Then the investigators will offer the treatment type (any of the above 5 experimental types) with the highest efficacy for each participant. In other words, the investigators will offer an optimized treatment after the one year and a half.
The eligibility criteria for enrolling individuals into this study are: 50 y<age<95 y, 5<MoCA<24.
Exclusion criteria are any of the followings:
- 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
The global objective of the proposed study is to investigate the effects of different tES in improving the cognitive status of older adults with dementia, when paired simultaneously with cognitive training. The general objectives include the following:
- Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
- Investigate the correlation of fNIRS outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on balance for older adults with cognitive impairment.
- Investigate the correlation of EVestG outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictively to the treatment at baseline.
- Disseminate the project results and design the next follow up project.
- Conditions
- Dementia
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Gamma Transcranial Alternating Current Stimulation (tACS), Theta Transcranial Alternating Current Stimulation (tACS), Sham, Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus
- Keywords
- transcranial electrical stimulation
- Medical subject headings
- Dementia
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 participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
Gamma Transcranial Alternating Current Stimulation (tACS)Device
A light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
Theta Transcranial Alternating Current Stimulation (tACS)Device
A light electrical current with personalized theta frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
ShamDevice
Sham stimulation (i.e. only slight stimulation at the beginning and at the end for a few seconds with majority of the time having no stimulation) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
Gamma Transcranial Alternating Current Stimulation (tACS)-PrecuneusDevice
A light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
Bilateral DLPFCDevice
A light electrical current applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. First 30-min treatment will target left DLPFC and second 30-min treatment will target right DLPFC. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Participants will receive tDCS simultaneously with cognitive exercises for one month every day excluding weekends. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Gamma Transcranial Alternating Current Stimulation (tACS) | Experimental | Participants will receive personalized gamma tACS simultaneously with cognitive exercises for one month every day excluding weekends. Receives: Device: Gamma Transcranial Alternating Current Stimulation (tACS) |
| Theta Transcranial Alternating Current Stimulation (tACS) | Experimental | Participants will receive personalized theta tACS simultaneously with cognitive exercises for one month every day excluding weekends. Receives: Device: Theta Transcranial Alternating Current Stimulation (tACS) |
| Sham Stimulation | Experimental | Participants will receive sham stimulation simultaneously with cognitive exercises for one month every day excluding weekends. Receives: Device: Sham |
| Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus | Experimental | Participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Receives: Device: Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus |
| Bilateral DLPFC | Experimental | Applying the optimal tES over left and right DLPFC. First 30-min will target the left DLPFC similar to the other arms, and the second 30-min treatment will target tES to the right DLPFC (one electrode over right DLPFC and one electrode over contralateral supraorbital area). Receives: Device: Bilateral DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale (ADAS-Cog)
11 tasks include the participant completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis. The score ranges from 0 to 70 where higher score indicates greater cognitive impairment.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Wechsler Memory Scale (WMS-IV)
Cognitive and memory task that focuses on 6 major memory indexes: auditory memory, visual working memory, immediate memory, delayed memory, and recognition memory. The score ranges from 40 to 160 where the lower score indicates greater cognitive impairment.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Secondary outcomes (12)
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Questionnaire used to assess neuropsychiatric symptoms and caregiver burden. The score 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 participant is exhibiting more severe changes in behaviours.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Montgomery-Asberg Depression Rating Scale (MADRS)
Questionnaire which measures mental health and more specifically depression severity where participant rates answers from zero to 6 for 10 questions. The score ranges from 0 to 60 with higher score indicating increased severity of depression.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Functional Near Infrared Spectroscopy (fNIRS)
Device designed mainly to measure blood flow over the prefrontal cortex. Participants will perform math and N-back task while fNIRS measures the signals simultaneously.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
EEG power in theta band
The theta band power will be calculated from each EEG recording.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9), and pre- and post-treatment EEG for 3 treatments days
EEG power in gamma band
The gamma band power will be calculated as the average from the tasks performed during EEG recording.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Peak gamma frequency from EEG
The peak gamma frequency will be calculated from each EEG recording.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Peak theta frequency from EEG
The peak theta frequency will be calculated as the average from the tasks performed during EEG recording.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Postural Sway from balance assessment
Postural sway (i.e. peak frequency of sway) will be measured using accelerometers placed on the back and ankle of the participant.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Vestibular Disorders Activities of Daily Living Scale (VADL)
VADL (vestibular disorders activities of daily living scale) will be recorded which is a questionnaire with 28 items rated from 1 to 10. Minimum score of 28 with maximum score of 280. This will be used in the analysis of balance data.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
BMI
Height and weight will be recorded for each participant in order to calculate BMI. This will be taken into account for analyzing balance data.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Width of EVestG signal
The width of the action potential from the EVestG signal will be analyzed for changes due changes in vestibular system and its functioning.
Measured: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Blood Pressure
Blood pressure measurement will be recorded for each participant 3 times. This will be taken into account for analyzing EVestG and fNIRS.
Measured: For each 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.
- First posted9 Aug 2024
- Study start20 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- All participants receive all 4 treatments in a randomized order with washout period of 2-5 months. After finishing all 4 treatments, participants receive one more treatment protocol after the washout period where the participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Once they complete the Pz protocol, participants will receive their optimal treatment with the first 30-min targeting the left DLPFC and the second 30-min targeting the right DLPFC (one electrode over right DLPFC and one over contralateral supraorbital area).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547021
- Sponsor's protocol ID
- HS26590 (B2024:091)
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Different Frequencies of Transcranial Electrical Stimulations Paired With Cognitive Training on the Executive Brain Functions in Dementia Population
- ClinicalTrials.gov ID
- NCT06547021
- Acronym / sponsor ID
- HS26590 (B2024:091)
- Conditions
- Dementia
- Keywords
- transcranial electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia is a prevalent condition with no known cure. It affects not only the person with dementia but also the family. This study will investigate the effects of applying different transcranial electrical stimulation (tES) waveforms to find the optimal stimulation when paired with cognitive exercise on older adults with dementia. It is a placebo-controlled double-blind study with statistical rigor. In addition, the investigators will investigate technological methods to monitor changes due to the intervention. These include functional near infrared spectroscopy (fNIRS), electroencephalography (EEG), electrovestibulography (EVestG), and balance measurements using accelerometers. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention. EEG measures the electrical activity of the brain via electrodes placed on the scalp to study the brain's response to different electrical stimulations treatments. EVestG is a non-invasive measure of the vestibuloacoustic system in both background (no motion) and in response to passive whole-body tilt stimuli. We hypothesize there is a direct link between vestibular system deficiencies and Alzheimer's. Lastly, the investigators will measure the effects of electrical stimulation on balance by measuring postural sway using two accelerometers.
This study investigates the effects of transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) with different protocols for frequencies to determine the most effective treatment to improve cognitive abilities and working memory for people with dementia.
The global objective of the proposed study is to investigate the effects of different tES in improving the cognitive status of older adults with dementia, when paired simultaneously with cognitive training. The general objectives include the following:
- Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
- Investigate the correlation of fNIRS outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on balance for older adults with cognitive impairment.
- Investigate the correlation of EVestG outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictively to the treatment at baseline.
- Disseminate the project results and design the next follow up project.
Detailed description
About 100 participants with either mild cognitive impairment (MCI) or a probable early or moderate dementia type excluding Parkinsonian dementia (as confirmed by their treating physician), will be recruited and tested over the course of this study.
Participants will have the option to choose to do the stimulation and cognitive exercise from home or at Riverview Health Centre. However, all assessments will be completed at Riverview Health Centre. One of the main limitations of human research is the small sample size as recruitment and enrollment of eligible participants especially in dementia population is a major challenge. Thus, a longitudinal study. Each participant will receive all 4 tES protocols in a randomized order while playing cognitive exercises:
- Personalized gamma tACS
- Personalized theta tACS
- tDCS (zero frequency)
- Sham tES The protocol for all tES treatments will be 4 weeks, 5 days/week (excluding weekends), two 30-min training sessions/day with 15 to 30 min break in between, all tutored either in-person or virtually. Participants will be assessed the week before each new treatment block, within a week of post-treatment and a month after the end of treatment block (follow-up). Between the different tES treatment protocols, 8-week to 20-week washout period will take place with no treatment. The time period for each participant to receive all 4 protocols will be around one year and a half depending on the duration of the washout period. After the participant completes all 4 protocols, there is one more treatment protocol where the participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Then the investigators will offer the treatment type (any of the above 5 experimental types) with the highest efficacy for each participant. In other words, the investigators will offer an optimized treatment after the one year and a half.
The eligibility criteria for enrolling individuals into this study are: 50 y<age<95 y, 5<MoCA<24.
Exclusion criteria are any of the followings:
- 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
The global objective of the proposed study is to investigate the effects of different tES in improving the cognitive status of older adults with dementia, when paired simultaneously with cognitive training. The general objectives include the following:
- Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
- Investigate the correlation of fNIRS outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
- Investigate the effects of different tES on balance for older adults with cognitive impairment.
- Investigate the correlation of EVestG outcomes with those of the primary outcome measures of the study in Objective 1 as well as its predictively to the treatment at baseline.
- Disseminate the project results and design the next follow up project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- All participants receive all 4 treatments in a randomized order with washout period of 2-5 months. After finishing all 4 treatments, participants receive one more treatment protocol after the washout period where the participant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. Once they complete the Pz protocol, participants will receive their optimal treatment with the first 30-min targeting the left DLPFC and the second 30-min targeting the right DLPFC (one electrode over right DLPFC and one over contralateral supraorbital area).
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Participants will receive tDCS simultaneously with cognitive exercises for one month every day excluding weekends. |
| Gamma Transcranial Alternating Current Stimulation (tACS) | Experimental | Device: Gamma Transcranial Alternating Current Stimulation (tACS)Participants will receive personalized gamma tACS simultaneously with cognitive exercises for one month every day excluding weekends. |
| Theta Transcranial Alternating Current Stimulation (tACS) | Experimental | Device: Theta Transcranial Alternating Current Stimulation (tACS)Participants will receive personalized theta tACS simultaneously with cognitive exercises for one month every day excluding weekends. |
| Sham Stimulation | Experimental | Device: ShamParticipants will receive sham stimulation simultaneously with cognitive exercises for one month every day excluding weekends. |
| Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus | Experimental | Device: Gamma Transcranial Alternating Current Stimulation (tACS)-PrecuneusParticipant will receive tACS at the personalized gamma over the regular placement of electrodes (left dorsolateral prefrontal cortex and the reference electrode on the contralateral supraorbital area) for the first 30-min training session and then over the precuneus (one electrode over Pz on the 10-20 EEG system and the other over the right deltoid muscle) during the second 30-min training session. |
| Bilateral DLPFC | Experimental | Device: Bilateral DLPFCApplying the optimal tES over left and right DLPFC. First 30-min will target the left DLPFC similar to the other arms, and the second 30-min treatment will target tES to the right DLPFC (one electrode over right DLPFC and one electrode over contralateral supraorbital area). |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MoCA score between 5 and 24
- Between the age of 50 and 95 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)A light electrical current with zero frequency (tDCS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Transcranial Direct Current Stimulation (tDCS) |
| Gamma Transcranial Alternating Current Stimulation (tACS)A light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Gamma Transcranial Alternating Current Stimulation (tACS) |
| Theta Transcranial Alternating Current Stimulation (tACS)A light electrical current with personalized theta frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Theta Transcranial Alternating Current Stimulation (tACS) |
| ShamSham stimulation (i.e. only slight stimulation at the beginning and at the end for a few seconds with majority of the time having no stimulation) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Sham Stimulation |
| Gamma Transcranial Alternating Current Stimulation (tACS)-PrecuneusA light electrical current with personalized gamma frequency (tACS) will be applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus |
| Bilateral DLPFCA light electrical current applied to the participants' scalp via 2 electrodes, while the participants perform cognitive exercises with the guidance of a trained research assistant. First 30-min treatment will target left DLPFC and second 30-min treatment will target right DLPFC. Cognitive exercises will be performed through the "Mind Triggers" app on an iPad where the participants perform memory and learning games/tasks. | Device | Bilateral DLPFC |
Primary outcome
Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
11 tasks include the participant completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis. The score ranges from 0 to 70 where higher score indicates greater cognitive impairment.
Wechsler Memory Scale (WMS-IV)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Cognitive and memory task that focuses on 6 major memory indexes: auditory memory, visual working memory, immediate memory, delayed memory, and recognition memory. The score ranges from 40 to 160 where the lower score indicates greater cognitive impairment.
12 secondary outcomes
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Functional Near Infrared Spectroscopy (fNIRS)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
EEG power in theta band
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9), and pre- and post-treatment EEG for 3 treatments days
EEG power in gamma band
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Peak gamma frequency from EEG
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Peak theta frequency from EEG
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Postural Sway from balance assessment
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Vestibular Disorders Activities of Daily Living Scale (VADL)
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
BMI
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Width of EVestG signal
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Blood Pressure
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS), Gamma Transcranial Alternating Current Stimulation (tACS) and Theta Transcranial Alternating Current Stimulation (tACS) in people with Dementia, 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 14 Nov 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 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 14 Nov 2025.