Clinical trial NCT06877312: Longitudinal Study to Investigate Different Transcranial Electrical Stimulation
Official title: Longitudinal Study to Investigate Different Treatment Protocols of Transcranial Electrical Stimulation for Individuals with Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia; Degenerative, Dementia Mixed
Keywords: dementia, alzheimer, cognitive impairment
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale (ADAS-Cog)
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
measure: Wechsler Memory Scale (WMS-IV)
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Secondary outcomes:
measure: N-Back
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
measure: Neuropsychiatric Inventory Questionnaire (NPIQ)
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
measure: Functional Near Infrared Spectroscopy (fNIRS)
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
measure: Virtual Reality Navigation (VRN) spatial orientation test
timeFrame: For each tES treatment: Baseline (week 0), Post-treatment (week 5), 1-month follow-up (week 9)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
Study officials:
References: