About this trial
Cerebral small vessel disease (cSVD) is characterized by an alteration of the structure and function of small penetrating brain arteries. Highly prevalent in older individuals from the general population, it represents a leading cause of stroke and a major contributor to cognitive decline and risk of dementia.
Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. The aim of the present study is to identify novel electroencephalographic (EEG) biomarkers of the cognitive deficits associated with cSVD, and how these biomarkers and cognitive performance are affected by personalized cognitive training or transcranial alternating current stimulation (tACS), a non-invasvie brain stimulation technique.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients included or previously included in the SHIVA cohort
Basic computer skills (ability to open a browser, use a mouse and keyboard)
Access to a personal computer with an internet connection
Independent in Activities of Daily Living (ADL) with a score ≥ 5/6, and in Instrumental Activities of Daily Living (IADL) with a score ≥ 4/8
Disqualifiers
Motor impairments preventing the use of a keyboard and mouse (e.g., motor issues related to severe hand osteoarthritis)
Depressive symptoms indicated by a score of 2 to 4 on the mini Geriatric Depression Scale (mini GDS), which includes 4 items
Age-related macular degeneration (AMD)
Untreated glaucoma
Trial design
Parallel
Treatments tested in this trial
Home-based cognitive training
DeviceAll interventions will be carried out for both groups of participants, with either minimal or extensive cSVD. Upon enrollment, each participant will undergo two hospital visits (visit 1 at day 0, visit 2 at day 7), followed by a home-based cognitive training across 10 days (days 15-24), two more hospital visits (visit 3 at day 26, visit 4 at day 33), and finally a follow-up cognitive testing at home after 6 months.
Treatment groups
Trial outcomes
Primary outcomes
EEG signal power
The primary outcome measure is the average EEG signal power (across different frequency bands and for various electrodes) between the two participant groups with either minor or extensive cSVD
Sponsors and contacts
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