Spontaneous Eye Blinking in Disorders of Consciousness
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 paramete
| Condition(s) | Disorders of Consciousness |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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). |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
| Locations | Liège, Belgium, Belgium; Burgau, Germany, Germany; Munich, Germany, Germany; Sant'Angelo dei Lombardi, AV, Italy; Ferrara, Italy, Italy; Florence, Italy, Italy (+2 more sites) |
| Start date | 2025-03-31 |
| NCT ID | NCT06323031 |
| Official listing | https://clinicaltrials.gov/study/NCT06323031 |