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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how small blood vessel problems in the brain, common in older adults, affect thinking and memory. The study aims to find new brain activity patterns (using a test called EEG) that are linked to these thinking difficulties. It will also explore whether personalized brain training or a gentle, non-invasive brain stimulation method (called tACS) can help improve thinking skills in people with this condition.

People who might take part are those aged 65 to 74 who have already been part of a related study called SHIVA, can use a computer and the internet, and are able to manage daily activities on their own. Participants will be asked to do some thinking tests and might receive either brain training exercises or brain stimulation. The study is not yet recruiting, and some health conditions or implanted medical devices may prevent participation. The goal is to better understand and eventually improve thinking problems related to small vessel disease in the brain.

Gender

ALL

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