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

NCT07068620 | Recruiting

• 1 other identifier: CHUBX 2024-81
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stroke; Cognitive Complaint; Cerebral Small Vessel Disease

Keywords

Cognitive decline; dementia; stroke; small vessel disease; healthy brain aging; electroencephalography; neuromodulation; transcranial alternating current stimulation; cognitive training; cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• EEG signal power

  The primary outcome measure is the average EEG signal power (across different frequency bands and for various electrodes) between the two participant groups with either minor or extensive cSVD

  Day 0, Day 26, Day 33

Study Arms (2)

Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to each

EXPERIMENTAL

Personalized cognitive training using an AI algorithm (zone of proximal development and empirical success - ZPDES - multi-arm algorithm), with a non-linear learning path adapted to each participant.

Device: Home-based cognitive training

Traditional cognitive training

ACTIVE COMPARATOR

Traditional cognitive training using a "staircase" method, featuring a linear progression.

Device: Home-based cognitive training

Interventions

Home-based cognitive training DEVICE

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.

Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to each; Traditional cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Stroke; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

IGOR SIBON, MD, PhD

CONTACT

0556795313; igor.sibon@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 16, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): March 7, 2028
• Study Completion (Estimated): March 7, 2028
• Last Updated: February 2, 2026

Record last verified: 2025-07

Locations

FR (1)