NCT07068620 · RECRUITING
Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys
This study is testing whether home-based computer cognitive training and a gentle form of non-invasive brain stimulation called tACS can improve thinking and memory in people who have cerebral small vessel disease — tiny blood vessel damage in the brain that raises stroke and dementia risk. Researchers also want to find EEG brain-wave patterns that signal cognitive trouble early. This is a Phase NA observational and intervention study, meaning it is exploratory rather than a late-stage treatment trial.
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-02