Spontaneous Eye Blinking in Disorders of Consciousness
ConditionDisorders of Consciousness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi ETS
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 groupSponsors and collaborators
Fondazione Don Carlo Gnocchi ETS
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