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New treatment option for Cerebral Small Vessel Disease
Official title Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys
ClinicalTrials.gov ID: NCT07068620
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.