Investigating the Effect of Different Frequencies of Transcranial Electrical Stimulations Paired With Cognitive Training on the Executive Brain Functions in Dementia Population

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 95
Healthy Volunteers: f
View:

• MoCA score between 5 and 24

• Between the age of 50 and 95 years old

Locations
Other Locations
Canada
Riverview Health Centre
RECRUITING
Winnipeg
Contact Information
Primary
Shelly Rempel-Rossum
Shelly.rempelrossum@umanitoba.ca
204-789-3389
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov