Brain activity and thinking problems in cerebral small vessel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll 80 participants aged 60 and older from the SHIVA cohort and divide them by the extent of white matter lesions on MRI (minimal versus extensive). They will record EEG during cognitive testing to identify electrical biomarkers associated with cSVD-related cognitive deficits. Participants will then receive personalized home-based cognitive training or transcranial alternating current stimulation (tACS) to test whether these interventions change EEG markers and cognitive performance. Primary outcomes include changes in EEG patterns and standardized cognitive scores, along with intervention tolerability.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: IGOR SIBON, MD, PhD
• Email: igor.sibon@chu-bordeaux.fr
• Phone: 0556795313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.