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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Home-based cognitive training

All interventions will be carried out for both groups of participants, with either minimal or extensive cSVD. Upon enrollment, each participant will undergo two hospital visits (visit 1 at day 0, visit 2 at day 7), followed by a home-based cognitive training across 10 days (days 15-24), two more hospital visits (visit 3 at day 26, visit 4 at day 33), and finally a follow-up cognitive testing at home after 6 months.

Locations (1)

CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire
Bordeaux, France