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

Recruiting now · Not applicable

Conditions studied: Cerebral Small Vessel Disease, Stroke, Cognitive Complaint

In brief

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.

Key facts

Study ID

NCT07068620

Run by

University Hospital, Bordeaux

People needed

80

Starts

2025-08-07

Expected to finish

2028-03-07

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire — Bordeaux, France (enrolling)

Full record on ClinicalTrials.gov

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