RecruitingNAINTERVENTIONAL

Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2

This research study aims to understand how different types of brain damage, such as those caused by strokes, injuries, or certain brain conditions, affect a person's thinking skills. The researchers will be working with two groups: adults who have specific thinking difficulties due to brain damage, and healthy volunteers. They use a combination of detailed thinking tests (called neuropsychological tests) and advanced brain scanning techniques, like MRI, to see how the brain is working. They might also use a gentle technique called Galvanic Vestibular Stimulation (GVS). The main goal is to figure out the exact brain changes that lead to these thinking problems, which could help develop better ways to diagnose and potentially treat them in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Caen

Enrolment target

400

Start

10 Jan 2019

Estimated completion

01 Jun 2030

Cerebrovascular Disorders Brain Lesion Degenerative Disease Developmental Disability

What is this study about?

This study, called the "Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2," is all about understanding how brain damage affects how we think and process information. Our brains are incredibly complex, and damage from things like a stroke, an injury, a growth (tumour), or even certain long-term (degenerative) or developmental conditions can sometimes change how well we remember, pay attention, or solve problems.

The researchers want to look closely at these thinking difficulties. They will compare two groups of people: first, adults who have experienced brain damage leading to specific thinking challenges, and second, healthy adults who don't have these issues. By comparing these groups, they hope to get a clearer picture of what's happening in the brain.

To do this, they’ll use a combination of methods. This includes detailed tests that check different thinking abilities (like memory, language, or attention) and advanced brain imaging techniques. These scans, like MRI, allow doctors to see the structure and activity of the brain without any surgery. They might also explore a gentle technique called Galvanic Vestibular Stimulation (GVS), which involves very mild electrical currents near the ear to see if it affects brain activity. The overall aim is to shed light on how brain damage leads to thinking problems, which could pave the way for better ways to help people in the future.

Key takeaways

Study is for adults with brain damage and healthy volunteers.
Aims to understand how brain damage affects thinking abilities.
Uses thinking tests and advanced brain scans (MRI).
May involve gentle electrical stimulation (GVS).
Participation helps future understanding and potential treatments.
You can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and able to speak French. Women who could become pregnant must be using effective birth control during the study. You'll also need to give your informed consent, which means you understand the study and agree to take part.

If you have brain damage, you might be able to join if it's due to a specific event like a stroke, injury, or a condition that affects your brain from birth or develops over time, and if it has caused some thinking difficulties. You should also not drink alcohol the day before any study appointments.

Some people can't take part. This includes healthy volunteers with a history of certain serious brain or mental health conditions, and patients with severe confusion, depression, or anxiety. You also can't be taking certain medications, be pregnant or breastfeeding, have problems with your vision or hearing that are too severe, or have conditions that would make an MRI scan unsafe. If you've been in another clinical trial very recently, you might also not be eligible.

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.

Are you 18 years or older?
Do you speak French?
If you are a woman who could become pregnant, are you using effective birth control?
If you have brain damage, is it due to conditions like a stroke, injury, or a developmental/degenerative disease, causing thinking problems?
Do you feel generally well enough to participate, without severe confusion, depression, or anxiety?
Are you able to have an MRI scan safely (e.g., no pacemakers, certain metal implants)?
Have you avoided other clinical trials in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a detailed discussion with the study team to fully understand what's involved and to give your informed consent. You'll undergo various assessments, which will include detailed tests of your thinking abilities, often called neuropsychological tests. You will also have several brain scans using advanced imaging techniques like MRI, which helps researchers see inside your brain.

Some participants might also experience Galvanic Vestibular Stimulation (GVS). This involves tiny electrical currents delivered through electrodes, usually placed behind the ears. It's generally a gentle and non-invasive procedure. You will likely have multiple visits to the study centre, and the total duration of your involvement will depend on the specific parts of the study you participate in. You should not drink alcohol the day before any appointments.

Potential risks and benefits

Taking part in research always has potential benefits and risks. You might not directly benefit from this study, but your participation will help doctors better understand how brain damage affects thinking, which could lead to improved care for others in the future. Potential risks could include discomfort from the brain scans if you're not comfortable in enclosed spaces, or minor side effects from GVS like a tingling sensation or temporary dizziness. All procedures are carefully monitored. Remember, your participation is voluntary, and you can withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Caen University Hospital
Verified postcode
Caen, France· Recruiting

Common questions

What kind of brain damage are they looking at?

They are looking at damage from strokes, injuries, tumours, certain infections, and long-term (degenerative) or developmental brain conditions.

What are 'neuropsychological tests'?

These are special tests and puzzles that help doctors measure different thinking skills like memory, attention, language, and problem-solving.

What is 'brain imaging'?

This refers to special scans, like an MRI, that create detailed pictures of your brain without any surgery, showing its structure and how it's working.

What is Galvanic Vestibular Stimulation (GVS)?

GVS is a gentle technique where very small electrical currents are used near the ear. It's being explored to see how it affects brain activity.

Will this study cure my condition?

This is a research study to understand brain damage better. While it might not directly cure your condition, the information gained could lead to better treatments in the future.

How to find out more

Olivier MARTINAUD, MD, PhD

martinaud-o@chu-caen.fr 2 31 06 46 17 Official trial record

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