Investigating Different Frequencies of Transcranial Electrical Stimulations in Dementia Population
NCT Number: NCT06547021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia
Interventions: DEVICE: Transcranial Direct Current Stimulation (tDCS)|DEVICE: Gamma Transcranial Alternating Current Stimulation (tACS)|DEVICE: Theta Transcranial Alternating Current Stimulation (tACS)|DEVICE: Sham
Sponsor: University of Manitoba
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2027-08-31

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), 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. 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. Disseminate the project results and design the next follow up project.

Primary Outcome Measures: 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., 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., For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)
Secondary Outcome Measures: 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., 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., 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., 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., For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)|EEG power in gamma band, The gamma band power will be calculated as the average from the tasks performed during EEG recording., 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., 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., 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., 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., 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., For each treatment: baseline (week 0), post-treatment (week 5), 1-month follow-up (week 9)