Longitudinal Study to Investigate Different Transcranial Electrical Stimulation

Not Applicable

Recruiting

• Conditions: Dementia; Degenerative, Dementia Mixed

• Registration Number: NCT06877312
• Lead Sponsor: University of Manitoba

Brief Summary

This research investigates the effect of different frequencies of tACS (0 Hz, 30 Hz, 50 Hz, 70 Hz, 90 Hz) and tRNS with cognitive exercises in a regimen protocol of weeks, everyday. The study design is a longitudinal study design in which participants receive different tES randomly ordered. Treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tES treatment type. Participants have the option of having their choice of music in the background while they perform cognitive exercise.

Detailed Description

This research will investigate the effect of applying transcranial electrical stimulation (tES) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. In addition, the investigators will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. Since most technological intervention on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. The investigators will use Egocentric Spatial Assessment using our Virtual Reality Navigation (VRN) and functional near infrared spectroscopy (fNIRS) measurements and analysis to develop the monitoring technologies. VRN measures how people orient themselves in a non-familiar environment; the investigators hypothesize it is deteriorated significantly in Alzheimer's even at its onset. fNIRS measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.

Study Timeline

• Study Start: 2024-10-09
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2030-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ability to read, write and speak English fluently
• MoCA score between 5 and 24

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 Hhistory 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
• Plan to change the medication during any treatment period (5 weeks including the pre-post assessments)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Wechsler Memory Scale (WMS-IV)	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	Change from baseline Wechsler Memory Scale (WMS-IV) Older Adult Battery Score at five and nine weeks.; Cognitive and memory task that focus on 6 major memory indexes: Auditory Memory, Visual Memory, Visual Working Memory, Immediate Memory, Delayed Memory, and Recognition Memory.
Alzheimer's Disease Assessment Scale (ADAS-Cog)	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	Change from baseline ADAS-Cog to 5 and 9 weeks. 11 tasks that include the subject completing tests and observer based assessments. It assesses cognitive domains of memory, language and praxis.

Secondary Outcome Measures

Name	Time	Method
N-Back	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	N is a number between 1 and 4. A sequence of random shapes is presented and the participant has to tap or say if (remember) whether a presented object is a repeat of the Nth previous object. We will use this test with N=1 as for N\>1 is very challenging for dementia population to perform.
Neuropsychiatric Inventory Questionnaire (NPIQ)	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	Questionnaire used to assesses neuropsychiatric symptoms and caregiver burden The score of the NPIQ 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 the participant is exhibiting more severe changes in behaviors.
Functional Near Infrared Spectroscopy (fNIRS)	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	fNIRS is a device designed mainly for measuring the blood flow over the prefrontal cortex. Participants will perform a verbal fluency task while the fNIRS measures signals simultaneously.
Virtual Reality Navigation (VRN) spatial orientation test	For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)	The VRN test will be run in non-immersive mode using a large screen and joystick in the PI's office at Riverview Health Center by one of the VRN team member (a research assistant). This program runs only on PC. Run the "rummeego.bat" file in the folder VRN V5 to run the program. Press "s" button to rotate the building. Pressing "Esc" exits that trial and goes to next. The VRN has two stages: 1) Localization, 2) Navigation. The second stage will be carried out only if a participant can pass the localization stage with a score \>15 (basically with no consistent side error).

Trial Locations

Locations (1)

Riverview Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada