Spontaneous Eye Blinking in Disorders of Consciousness
Recruiting now
Conditions studied: Disorders of Consciousness
In brief
Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC). This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months.
Key facts
- Study ID
- NCT06323031
- Run by
- Fondazione Don Carlo Gnocchi ETS
- People needed
- 70
- Starts
- 2025-05-08
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Instituto de Rehabilitación Neurológica IRENEA — Valencia, Spain, Spain (enrolling)
- Therapiezentrum Burgau — Burgau, Germany, Germany (enrolling)
- Dipartimento di Neurologia, LMU Hospital, LMU Munich — Munich, Germany, Germany (enrolling)
- Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS — Sant'Angelo dei Lombardi, AV, Italy (enrolling)
- Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara — Ferrara, Italy, Italy (enrolling)
- IRCCS Fondazione Don Gnocchi ONLUS — Florence, Italy, Italy (enrolling)
- IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS — Milan, Italy, Italy (enrolling)
- Coma Science Group, GIGA-Consciousness, University of Liege — Liège, Belgium, Belgium
Full record on ClinicalTrials.gov
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