RecruitingNot ApplicableNCT07068620

Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys

Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort - SHIVA-CogNeurophys

Sponsor

University Hospital, Bordeaux

Enrollment

80 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Cognitive Complaint Cerebral Small Vessel Disease

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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
Informed and written consent signed by the participant and the investigating physician for this study

Exclusion Criteria21

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
Untreated psychiatric conditions that interfere with cognitive assessments
Diagnosed attention deficit disorder with or without hyperactivity or patients who could not complete all cognitive tests required in the SHIVA cohort
Systemic diseases that cause cognitive changes, such as obesity and metabolic disorders
History of epilepsy or seizures
Scalp sensitivity or skin lesions (dermatitis, wounds, etc.)
Contraindications for the use of electrical stimulation:
Surgical clips, metal sutures, staples, stents
Osteosynthesis material in the head or neck
Pacemaker
Implanted hearing aid
Ocular foreign bodies, shrapnel, bullets
Metalworker
Pacemaker or neurostimulator
Heart valve or endovascular material
Ventricular shunt valve
Recent exposure (< 6 months) to brain stimulation (tDCS, TMS, etc.)
Ongoing participation in a clinical trial or cognitive training program

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Interventions

DEVICEHome-based cognitive training

All 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.