An interventional study of Transcranial Direct Current Stimulation (tDCS) and Gamma Transcranial Alternating Current Stimulation (tACS) in Dementia, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 50 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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:
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:
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:
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:
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 100 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive tDCS simultaneously with cognitive exercises for one month every day excluding weekends.
Device: Transcranial Direct Current Stimulation (tDCS)
Participants will receive personalized gamma tACS simultaneously with cognitive exercises for one month every day excluding weekends.
Device: Gamma Transcranial Alternating Current Stimulation (tACS)
Participants will receive personalized theta tACS simultaneously with cognitive exercises for one month every day excluding weekends.
Device: Theta Transcranial Alternating Current Stimulation (tACS)
Participants will receive sham stimulation simultaneously with cognitive exercises for one month every day excluding weekends.
Device: Sham
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.
Device: Gamma Transcranial Alternating Current Stimulation (tACS)-Precuneus
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).
Device: Bilateral DLPFC
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.
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.
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 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.
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.
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.
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.
Time frame: 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.
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
The gamma band power will be calculated as the average from the tasks performed during EEG recording.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
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