Brain activity and thinking problems in cerebral small vessel disease
Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort - SHIVA-CogNeurophys
NA · University Hospital, Bordeaux · NCT07068620
This project will see if EEG brain signals and home-based cognitive training or tACS can detect and improve thinking problems in older adults with cerebral small vessel disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07068620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are SHIVA cohort participants aged 60 or older with evidence of cerebral small vessel disease who are independent in daily activities, have basic computer skills and internet access, and can give informed consent.
Not a fit: Patients with severe motor or visual impairments, untreated psychiatric disease or glaucoma, significant depressive symptoms, diagnosed attention deficit conditions that prevent testing, or who cannot use a computer or travel to Bordeaux are unlikely to benefit.
Why it matters
Potential benefit: If successful, this work could enable earlier detection of cSVD-related cognitive decline and offer noninvasive, personalized ways to improve thinking and daily function.
How similar studies have performed: Prior small studies have shown promising but mixed results for EEG biomarkers, cognitive training, and tACS in age-related cognitive impairment, but strong evidence specifically in cSVD is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Small Vessel Disease, Stroke, Cognitive Complaint, Cognitive decline, dementia, stroke, small vessel disease, healthy brain aging