Natural eye blinking to help tell levels of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter prospective observational study enrolling adults with disorders of consciousness after severe acquired brain injury at European rehabilitation and research centers. Investigators will record spontaneous eye-blink parameters (rate, amplitude, duration, variability) using EEG‑EOG during two 20‑minute resting sessions 24 hours apart, within two weeks of study entry. The planned sample includes about 70 patients across diagnostic groups (UWS, MCS–, MCS+) and 23 age- and sex-matched healthy controls, with clinical data collected alongside routine care and consent provided by legal representatives. Data will be analyzed to determine whether blink features relate to diagnosis and short-term prognosis without altering standard clinical management.

Why it matters

Who can join: the full rules

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).

Where it's running

• Therapiezentrum Burgau
  Burgau, Germany, Germany Recruiting
• Dipartimento di Neurologia, LMU Hospital, LMU Munich
  Munich, Germany, Germany Recruiting
• Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
  Sant'Angelo dei Lombardi, Av, Italy Recruiting
• Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara
  Ferrara, Italy, Italy Recruiting
• IRCCS Fondazione Don Gnocchi ONLUS
  Florence, Italy, Italy Recruiting
• IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Anna Estraneo, MD
• Email: aestraneo@dongnocchi.it
• Phone: 3396418648

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.