Spontaneous Eye Blinking in Disorders of Consciousness
This study is investigating whether looking at how people blink their eyes can help doctors better understand the differences between two severe conditions: Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS). After a serious brain injury, it can be very difficult for medical teams to tell these conditions apart, which can affect treatment decisions and what to expect for the future. Researchers are carefully observing the blinking patterns (like how often, how strongly, and for how long someone blinks) in patients recovering from severe brain injuries. They are doing this in several hospitals across Europe. The hope is that these blinking details might offer new clues for more accurate diagnosis and a better idea of a patient's potential for recovery.
At a glance
What is this study about?
This research is looking into how eye blinking can help us understand patients who are in a group of conditions called Disorders of Consciousness (DoC). These are really challenging situations where people have had a severe brain injury and are, in a general sense, not fully awake or aware.
Specifically, doctors sometimes find it very difficult to tell the difference between two conditions: Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS). In UWS, a person might seem awake but doesn't show signs of being aware of their surroundings. In MCS, a person might show small, but clear, signs of awareness, even if they can't communicate well. Knowing the difference is extremely important because it can affect how doctors provide care and what families can expect for their loved one's future. This study hopes that by looking closely at blinking patterns, they might find a clearer way to diagnose these conditions and even predict how a patient might recover.
This is an observational study, which means doctors will be carefully watching and recording information about patients as part of their usual care. It's happening in several hospitals across Europe and involves patients who have had a severe brain injury. They will also compare the findings to a group of healthy people to understand what normal blinking looks like. The study aims to gather clues that could lead to better tools for diagnosis and predicting recovery in the future.
Key takeaways
- This study investigates if blinking patterns can help diagnose difficult coma-like states.
- It aims to tell the difference between Unresponsive Wakefulness Syndrome and Minimally Conscious State.
- Participation involves two short, non-invasive recordings of blinking and brain activity.
- No new treatments or medications are given; it's an observational study.
- The results could lead to better tools for diagnosis and predicting recovery for future patients.
Who may be eligible?
This study is looking for adults aged 18 or older who are in a specific type of coma-like state (called Disorders of Consciousness) after a serious brain injury. This injury must have happened no more than six months before joining the study.
To be considered, patients must have received a clear diagnosis of one of these conditions (Unresponsive Wakefulness Syndrome, Minimally Conscious State minus, or Minimally Conscious State plus) after several detailed medical evaluations. It's also important that the patient didn't have any other known brain or mental health problems before their current injury.
Patients would not be able to join if they have other serious health problems at the time that could make them unstable, like breathing difficulties or a high fever. Also, if they have eye problems, eyelid injuries, have taken strong sedatives in the last 24 hours, or have had another brain incident since being admitted to the hospital, they would not be suitable for this study.
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.
- Is the patient 18 years old or older?
- Did the patient have a severe brain injury less than 6 months ago?
- Has a doctor diagnosed the patient with Unresponsive Wakefulness Syndrome or Minimally Conscious State?
- Are the patient's general health conditions stable (e.g., no fever, no severe breathing issues)?
- Does the patient have healthy eyes and eyelids, with no injuries or diseases affecting blinking?
- Has the patient avoided strong sedative medications in the past 24 hours?
What does participation involve?
If a patient is considered for this study, their legal representative (like a family member) will be given detailed information about the study and asked to sign a consent form. This means they agree for the patient to take part.
Taking part involves two special recordings, typically within two weeks of joining the study. Each recording will last about 20 minutes. During these recordings, electrodes will be placed on the patient's head (for an EEG) and around their eyes (for an EOG) to measure brain activity and eye movements, including blinking. These will be done while the patient is awake with their eyes open, usually at their bedside in a quiet, dimly lit room. These recordings will happen about 24 hours apart, always between 10 AM and 5 PM, to make sure the results are as clear and consistent as possible.
No extra medication or follow-up visits are required beyond the patient's usual medical care. The entire study for each patient will be integrated into their routine hospital stay, and the study itself will run for a maximum of 24 months in total across all hospitals.
Potential risks and benefits
Locations (8)
- Coma Science Group, GIGA-Consciousness, University of LiegeVerified postcodeLiège, Belgium· Not yet recruiting
- Therapiezentrum BurgauVerified postcodeBurgau, Germany· Recruiting
- Dipartimento di Neurologia, LMU Hospital, LMU MunichVerified postcodeMunich, Germany· Recruiting
- Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUSVerified postcodeSant'Angelo dei Lombardi, Italy· Recruiting
- Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria FerraraVerified postcodeFerrara, Italy· Recruiting
- IRCCS Fondazione Don Gnocchi ONLUSVerified postcodeFlorence, Italy· Recruiting
- IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUSVerified postcodeMilan, Italy· Recruiting
- Instituto de Rehabilitación Neurológica IRENEAVerified postcodeValencia, Spain· Recruiting
Common questions
What are 'Disorders of Consciousness'?
These are conditions where people have had severe brain injuries and are not fully awake or aware, often described as coma-like states.
What is the difference between UWS and MCS?
UWS (Unresponsive Wakefulness Syndrome) means a person seems awake but shows no signs of being aware. MCS (Minimally Conscious State) means a person shows small, but clear, signs of awareness.
Will this study give my loved one a new medication?
No, this is an observational study. It only involves recording eye blinking and brain activity; no new medications or treatments are given.
How long will the recordings take?
There will be two recording sessions, each lasting about 20 minutes, usually done within two weeks of joining the study.
Can we change our mind about taking part?
Yes, the patient's legal representative can withdraw consent at any time without affecting the patient's care.
How to find out more
Anna Estraneo, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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