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Blink of an eye: new study tests simple test for consciousness disorders

NCT ID NCT06323031

Diagnosis Sponsor: Fondazione Don Carlo Gnocchi ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study looks at whether spontaneous eye blinking can help doctors tell the difference between two types of consciousness disorders: unresponsive wakefulness syndrome and minimally conscious state. Researchers will measure blinking patterns in 70 patients across 8 European centers. The goal is to see if blinking can serve as a simple, non-invasive diagnostic and prognostic tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a simple, non-invasive way to help doctors diagnose and predict recovery in patients with disorders of consciousness.
What could go wrong
This is an early observational study with only 70 participants, so results may not apply to all patients. Eye blinking may not be a reliable marker across different individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients in UWS or MCS due to severe acquired brain injury with different etiology (traumatic, anoxic, vascular) consecutively admitted at participating neurorehabilitation units. The total sample will be composed of 70 patients (n=9 pts per participating unit).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * clinical diagnosis of DoC (UWS, MCS minus, MCS plus) following repeated clinical evaluation (at least four CRS-R in a week) * age ≥ 18 years * time post-onset ≤6 months * Previous sABI of any etiology (traumatic, vascular, anoxic, mixed, etc.) * Negative anamnesis for neurological or psychiatric disorders. Exclusion Criteria: * unstable clinical conditions (e.g. respiratory failure, fever, status epilepticus, etc.); * ophthalmic diseases, or clinically detected peripheral damage in eyelid motility (e.g. orbital fracture); * intake of sedative drugs in the preceding 24 hours; * additional brain event following admission (e.g., stroke).

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disorders of consciousness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Coma Science Group, GIGA-Consciousness, University of Liege

    NOT_YET_RECRUITING

    Liège, Belgium, 4000, Belgium

  • Dipartimento di Neurologia, LMU Hospital, LMU Munich

    RECRUITING

    Munich, Germany, 81377, Germany

  • IRCCS Fondazione Don Gnocchi ONLUS

    RECRUITING

    Florence, Italy, 50143, Italy

  • IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

    RECRUITING

    Milan, Italy, 20148, Italy

  • Instituto de Rehabilitación Neurológica IRENEA

    RECRUITING

    Valencia, Spain, 46007, Spain

  • Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

    RECRUITING

    Sant'Angelo dei Lombardi, AV, 83054, Italy

  • Therapiezentrum Burgau

    RECRUITING

    Burgau, Germany, 89331, Germany

  • Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara

    RECRUITING

    Ferrara, Italy, 44124, Italy

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