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NCT07068620Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
4 Jul 2025
Start date
7 Aug 2025
Primary completion date
7 Mar 2028
Lead sponsor
University Hospital, Bordeaux
Diseases
Stroke
NCT number
NCT07068620

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 7 Aug 2025 to the primary completion date, 7 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Surgical clips, metal sutures, staples, stents

Other illness

  • 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
  • Heart valve or endovascular material

Age

  • Age-related macular degeneration (AMD)

Other

  • 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
  • Untreated glaucoma
  • Scalp sensitivity or skin lesions (dermatitis, wounds, etc.)
    • Contraindications for the use of electrical stimulation:
  • Osteosynthesis material in the head or neck
  • Pacemaker
  • Implanted hearing aid
  • Ocular foreign bodies, shrapnel, bullets
  • Metalworker
  • Pacemaker or neurostimulator
  • Ventricular shunt valve
    • Recent exposure (\< 6 months) to brain stimulation (tDCS, TMS, etc.)
    • Ongoing participation in a clinical trial or cognitive training program

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.