Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07068620

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

Led by University Hospital, Bordeaux · Updated on 2026-02-02

80

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 5/6, and in Instrumental Activities of Daily Living (IADL) with a score 65 4/8
  • Informed and written consent signed by the participant and the investigating physician for this study
Not Eligible

You will not qualify if you...

  • 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.)
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire

Bordeaux, France, 33000

Actively Recruiting

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Research Team

I

IGOR SIBON, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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