RecruitingNCT06323031

Spontaneous Eye Blinking in Disorders of Consciousness

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

70 participants

Start Date

Mar 31, 2025

Study Type

OBSERVATIONAL

Conditions

Disorders of Consciousness

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria4

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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