RecruitingOBSERVATIONAL

Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

Doctors are trying to understand how the brains of people with severe brain injuries work when they can't fully respond. This study focuses on patients who are unconscious or have a disorder of consciousness. We want to see if their brain activity changes when they hear familiar emotional sounds, like their own name spoken by someone they know, compared to a stranger's voice. We use a special test called an 'event-related potential' (ERP) which measures brain waves. By doing this, we hope to find more reliable ways to predict how these patients might recover and make better decisions about their care. It's about using personal sounds to get a clearer picture of what's happening in their brain.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

114

Start

25 Mar 2024

Estimated completion

01 Sep 2026

Disorder of Consciousness

What is this study about?

When someone has a severe brain injury, perhaps after a heart attack, stroke, or serious accident, they might become unconscious or have what doctors call a 'disorder of consciousness'. This means their brain isn't responding in the usual ways. It can be very difficult for doctors and families to know what these patients are aware of and how they might recover.

This study aims to make that understanding clearer. We're looking at specific brain responses using a test that measures electrical activity in the brain. Imagine hearing a sudden sound – your brain reacts. We're particularly interested in how the brain reacts to very personal, meaningful sounds, like hearing your own name. The idea is that a familiar voice saying your name might trigger a stronger, more telling brain response than a stranger's voice or a simple 'beep'.

By carefully observing these brain responses, especially through something called a 'P300 response' in brainwave measurements, we hope to get a better idea of how a patient's brain is working. This could help doctors make more accurate predictions about a patient's chances of recovery and guide important decisions about their care. Ultimately, we want to find better tools to help these highly vulnerable patients and their families.

Key takeaways

Aims to improve understanding of brain activity in people with severe brain injuries.
Uses brainwave tests (ERPs) with familiar and unfamiliar sounds, including one's own name.
Hopes to find better ways to predict recovery potential.
Focuses on patients in intensive care with a disorder of consciousness.
Participation involves non-invasive brain tests during hospital stay.
The study could lead to better tools for making decisions about patient care.

Who may be eligible?

To join this study, people must be adults (18 or older) who are currently in intensive care because of a severe brain injury. This could be from a heart attack, stroke, or a head injury. They must have a persistent disorder of consciousness, meaning they are not fully awake or aware, even after any medicines that make them sleepy have worn off.

We might also consider people who had a similar brain injury over six months ago (since April 2022) and had an earlier brain test that used only neutral sounds, like simple beeps, to check their brain activity. This study wants to see if using emotional sounds, like their own name spoken by a loved one, makes a difference.

However, there are also reasons why someone might not be able to join. For example, if they are already near the end of their life, are having severe health problems like uncontrolled low blood pressure during the brain test, are currently sedated, are pregnant, or are already known to be deaf. Also, anyone who has previously taken part in this specific study, is under legal protection, or isn't part of the social security system wouldn't be able to participate.

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 old or over?
Are you currently in intensive care due to a severe brain injury (e.g., from a heart attack, stroke, or head trauma)?
Do you have a persistent 'disorder of consciousness' (not fully awake or aware) after sedation has worn off?
Are you *not* currently pregnant?
Are you *not* known to be deaf?
Have you *not* previously participated in this specific study?

Answer every question to see your result.

What does participation involve?

This study involves specific brain activity tests while participants are in the intensive care unit. Researchers will use special equipment that measures brain waves while the participant listens to different sounds, including their own name spoken by a familiar person and by an unfamiliar person. The assessments for this study will take place during their hospital stay and will not require extra visits or medication. Overall, the involvement in the study is limited to the period of these brain tests while they are in the ICU. There is no long-term follow-up beyond this specific assessment.

Potential risks and benefits

The potential benefit of taking part is that the information gathered might help improve how doctors understand and predict recovery for patients with disorders of consciousness in the future. For the patient themselves, there are no direct medical benefits from participating. The risks are very low; the brainwave test is non-invasive and does not involve any pain or discomfort. It's similar to having a sticker placed on the skin. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Medical ICU, HEGP Hospital, APHP.Centre
Verified postcode
Paris, France· Not yet recruiting
Medical ICU, Cochin Hospital, APHP.Centre
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'disorder of consciousness'?

It means someone has a severe brain injury and isn't fully awake or aware, making it hard for them to respond.

What is an 'event-related potential' (ERP)?

It's a way to measure brain activity to see how the brain reacts to different sounds using special sensors placed on the head.

Why use someone's own name?

Researchers believe hearing something personal, like your own name from a loved one, might get a clearer brain response than other sounds, helping doctors assess brain activity.

Is this test painful?

No, the test is not painful. It simply involves placing sensors on the head to record brain waves, similar to measuring heart activity.

Will being in the study affect my loved one's care?

No, participating in the study will not change the medical care your loved one receives.

How to find out more

Sarah Benghanem, MD, MSc, PhD student

sarah.benghanem@aphp.fr 0033158412533 Official trial record

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