Loading clinical trials...
Loading clinical trials...
Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort - SHIVA-CogNeurophys
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.
cSVD is by far the most prevalent vascular contributor to cognitive impairment in the population. However, accurate quantitative estimates of the predictive ability of cSVD for risk of dementia are lacking. Moreover, stratification of cognitive decline and risk of dementia in cSVD patients according to imaging characteristics as well as evidence of coexisting neurodegenerative disease and vascular comorbidity are lacking. Moreover, there is currently no specific mechanism-based treatment, leading to empirical and heterogeneous clinical practice, which in most instances consists of ignoring these lesions. This clinical blind spot represents a major "missed opportunity" for the prevention of cognitive decline and dementia. This study aims to explore the electroencephalographic (EEG) characteristics of patients with either extensive or minimal neurovascular lesions due to cSVD in 80 patients above 60 years old. The main goal is to identify EEG biomarkers that characterize these lesions and the associated cognitive deficits. Secondary objectives aim to assess the potential impact of cognitive training paradigms and non-invasive brain stimulation (namely transcranial alternating current stimulation - tACS) on these biomarkers and on cognitive performance. Participants will be divided into two groups. The first group will consist of patients with no or minor white matter hyperintensities on brain MRI (i.e. features of minor cSVD) , while the second group will include patients with moderate to severe white matter hyperintensities (i.e., features of extensive cSVD). This exploratory study leverages the uniqueness of the SHIVA cohort, a deeply characterized resource for investigation of cSVD. To our knowledge, the combination of EEG recordings, cognitive training, and noninvasive brain stimulation in cSVD patients is entirely novel
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire
Bordeaux, France
Start Date
August 7, 2025
Primary Completion Date
March 7, 2028
Completion Date
March 7, 2028
Last Updated
February 2, 2026
80
ESTIMATED participants
Home-based cognitive training
DEVICE
Lead Sponsor
University Hospital, Bordeaux
NCT06258538
NCT07371455
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05093673