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RECRUITING
NCT06323031

Spontaneous Eye Blinking in Disorders of Consciousness

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

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.

Official title: Spontaneous Eye Blinking as a Diagnostic and Prognostic Marker in Patients With Disorders of Consciousness After Severe Acquired Brain Injury

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2025-03-31

Completion Date

2026-06

Last Updated

2025-09-29

Healthy Volunteers

Yes

Locations (8)

Coma Science Group, GIGA-Consciousness, University of Liege

Liège, Belgium, Belgium

Therapiezentrum Burgau

Burgau, Germany, Germany

Dipartimento di Neurologia, LMU Hospital, LMU Munich

Munich, Germany, Germany

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, AV, Italy

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

Ferrara, Italy, Italy

IRCCS Fondazione Don Gnocchi ONLUS

Florence, Italy, Italy

IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

Milan, Italy, Italy

Instituto de Rehabilitación Neurológica IRENEA

Valencia, Spain, Spain