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Spontaneous Eye Blinking in Disorders of Consciousness

Recruitingn/aAges 18 Years - anyAllFondazione Don Carlo Gnocchi ETS
NCT06323031 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

8 sites
Coma Science Group, GIGA-Consciousness, University of Liege
Liège, Belgium
Therapiezentrum Burgau
Burgau, Germany
Dipartimento di Neurologia, LMU Hospital, LMU Munich
Munich, Germany
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Italy
Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara
Ferrara, Italy
IRCCS Fondazione Don Gnocchi ONLUS
Florence, Italy
IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS
Milan, Italy
Instituto de Rehabilitación Neurológica IRENEA
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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