Recruiting

Transcranial Electrical Stimulation

Sponsor:

University of Manitoba

Code:

NCT06547021

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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 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:

1. Run a human research randomized and double-blind study to address the global objective of the study with statistical rigor.
2. 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.
3. Investigate the effects of different tES on EEG recordings as well as its predictivity to the treatment at baseline.
4. Investigate the effects of different tES on balance for older adults with cognitive impairment.
5. 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.
6. Disseminate the project results and design the next follow up project.

Conditions

Dementia

Study ID

NCT06547021

Start date

Sep 20, 2024

Status verified date

Aug, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • MoCA score between 5 and 24
  • Between the age of 50 and 95 years old

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Direct Current Stimulation (tDCS)

Participants will receive tDCS simultaneously with cognitive exercises for one month every day excluding weekends.

experimental: Gamma Transcranial Alternating Current Stimulation (tACS)

Participants will receive personalized gamma tACS simultaneously with cognitive exercises for one month every day excluding weekends.

experimental: Theta Transcranial Alternating Current Stimulation (tACS)

Participants will receive personalized theta tACS simultaneously with cognitive exercises for one month every day excluding weekends.

experimental: Sham Stimulation

Participants will receive sham stimulation simultaneously with cognitive exercises for one month every day excluding weekends.

experimental: Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus

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.

experimental: Bilateral DLPFC

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).

Interventions

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.

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.

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.

Sham

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)-Precuneus

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 DLPFC

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.

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) ]
  • Wechsler Memory Scale (WMS-IV) [ Time Frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9) ]

Central Contacts and Locations

Central contacts

Shelly Rempel-Rossum

204-789-3389Shelly.rempelrossum@umanitoba.ca

Locations

Riverview Health Centre

Recruiting

Winnipeg, Canada

Contacts

Moussavi

204-478-6163MARITERE.GARCIACAMPUZANO@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Nov 14, 2025

Last verified

Aug, 2025

Keywords

  • transcranial electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-11-14.