RecruitingNAINTERVENTIONAL

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

This study, called SHIVA-CogNeurophys, is all about Cerebral Small Vessel Disease (cSVD), a common condition in older people that can lead to strokes and memory problems. We want to understand how cSVD affects thinking and memory. We're using a special brainwave test called EEG (electroencephalogram) to find early signs of these changes. We're also exploring if home-based brain training or a gentle electrical brain stimulation (called tACS) can help improve thinking skills and the brainwave patterns. This research aims to find better ways to detect and manage cSVD, hopefully preventing future problems like memory loss and disability.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

07 Aug 2025

Estimated completion

07 Mar 2028

Cerebral Small Vessel Disease Stroke Cognitive Complaint

What is this study about?

Cerebral Small Vessel Disease (cSVD) is a common condition that affects the tiny blood vessels deep inside your brain. Think of your brain as a big city, and these small vessels are like the narrow side streets. When these streets get damaged, it can affect how the city works, leading to issues with thinking, memory, and even increasing the risk of strokes or dementia.

Currently, it's quite hard to spot and properly manage cSVD, which means we might be missing chances to help people before their symptoms get worse. This study aims to change that. We want to find new ways to identify the thinking and memory problems linked to cSVD using a special test called an electroencephalogram, or EEG. This test is completely safe and painless – it just involves placing sensors on your scalp to record your brain's electrical activity, like listening to your brain's conversation.

We also want to see if specific actions can improve these thinking skills and brain activity. We'll be looking at two approaches: tailored brain training exercises you can do at home, and a gentle brain stimulation technique called transcranial alternating current stimulation (tACS). TACS involves placing small electrodes on your head to deliver very mild electrical currents, which are designed to gently encourage brain activity. By understanding how these interventions affect brain activity and thinking, we hope to discover better ways to help people living with cSVD.

Key takeaways

The study investigates how small blood vessel damage in the brain affects thinking.
It uses EEG brainwave tests to find new ways to spot early changes.
Researchers are testing if brain training or gentle electrical stimulation can help.
The goal is to find better ways to prevent memory loss and disability from cSVD.
You must have been part of the SHIVA cohort previously to join.

Who may be eligible?

To join this study, you first need to have been part of the SHIVA study previously. You’ll also need to be 60 years or older and able to use a computer for basic tasks like browsing the internet, as well as being able to manage your daily activities and care for yourself.

There are some reasons why you might not be able to take part. For instance, if you have trouble using a computer mouse and keyboard due to movement difficulties, or if you have certain eye conditions like severe macular degeneration or untreated glaucoma. Other reasons include having significant depression, other untreated mental health conditions, certain serious long-term illnesses that affect your thinking, a history of seizures, or skin issues on your scalp.

Additionally, if you have any metal implants in your head or neck, like surgical clips, pacemakers, or certain stents, you won't be able to receive the brain stimulation part of the study. This also applies if you’ve recently had other types of brain stimulation or are currently in another clinical trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you previously taken part in the SHIVA study?
Are you 60 years old or older?
Can you use a computer for basic tasks (like clicking and typing)?
Are you able to manage your daily activities and care for yourself?
Do you have any metal implants in your head or neck (e.g., pacemaker, surgical clips)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of a group that has either minor or more noticeable signs of cSVD on brain scans. You will undergo EEG brainwave recordings, which are painless and involve placing sensors on your scalp. You'll also complete various thinking and memory tests. Depending on which group you're in, you might also take part in home-based computer brain training exercises or receive gentle electrical brain stimulation (tACS). The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might help us learn more about cSVD and how to treat it, which could benefit others in the future. You might also find that the brain training or stimulation helps your own thinking skills, though this is not guaranteed. As with any study, there are some small risks, such as mild discomfort from the brain stimulation, or feeling tired from the tests. However, all procedures are carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is Cerebral Small Vessel Disease (cSVD)?

It's a common condition, mostly in older people, where tiny blood vessels in the brain get damaged. This can affect thinking skills and increase the risk of stroke or memory problems.

What is an EEG test?

An EEG (electroencephalogram) is a safe and painless test that measures the electrical activity in your brain. Sensors are placed on your scalp, like listening to your brain's signals.

What is 'gentle electrical brain stimulation'?

This is a technique called tACS, where very mild electrical currents are delivered to your brain through small patches on your head. It's designed to gently encourage brain activity.

Will I have to take any new medicines?

No, this study does not involve taking any new medications. The interventions are home-based cognitive training or gentle brain stimulation.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point, for any reason, without needing to explain why, and it won't affect your future medical care.

How to find out more

IGOR SIBON, MD, PhD

igor.sibon@chu-bordeaux.fr 0556795313 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.