Spontaneous Eye Blinking in Disorders of Consciousness

NCT06323031 · tracked via the Priya Life Science Germany tracker

Sponsor

Fondazione Don Carlo Gnocchi ETS

Phase

Observational

Started

2025-05-08

Last updated

2026-07-13

Condition(s) studied

Disorders of Consciousness

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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).

Primary outcome measure(s)

Clinical Diagnosis — 6 months from enrollment
Clinical diagnosis as assessed by the Coma Recovery Scale-Revised (min. - max- score = 0-23, with higher scores indicating a higher level of consciousness)

Trial sites (8)

Facility	City	Region	Status
Coma Science Group, GIGA-Consciousness, University of Liege	Liège	Belgium	Not Yet Recruiting
Therapiezentrum Burgau	Burgau	Germany	Recruiting
Dipartimento di Neurologia, LMU Hospital, LMU Munich	Munich	Germany	Recruiting
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS	Sant'Angelo dei Lombardi	AV	Recruiting
Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara	Ferrara	Italy	Recruiting
IRCCS Fondazione Don Gnocchi ONLUS	Florence	Italy	Recruiting
IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS	Milan	Italy	Recruiting
Instituto de Rehabilitación Neurológica IRENEA	Valencia	Spain	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323031 on ClinicalTrials.gov ↗ ← All trials in Germany