Spontaneous Eye Blinking in Disorders of Consciousness
ConditionDisorders of Consciousness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
Qualifiers
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.)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
70 Participants
are grouped into 1 trial groupLocations
8Belgium
Coma Science Group, GIGA-Consciousness, University of Liege4000, LiègeBelgium, Belgium
Germany
Therapiezentrum Burgau89331, BurgauGermany, Germany
Dipartimento di Neurologia, LMU Hospital, LMU Munich81377, MunichGermany, Germany
Italy
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS83054, Sant'Angelo dei LombardiAV, Italy
Sponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Therapiezentrum Burgau
Collaborator
University of Liege
Collaborator
University Hospital Munich
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
VITHAS Valencia (Spain)
Collaborator
Lavezzi Susanna, Local Health Unit, Ferrara (IT)
Collaborator
Source ClinicalTrials.gov