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
This trial accepts healthy volunteersQualifiers
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 population
Patients in UWS or MCS due to severe acquired brain injury with different etiology (traumatic, anoxic, vascular) consecutively admitted at participating neurorehabilitation units. The total sample will be composed of 70 patients (n=9 pts per participating unit).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 1 trial groupGroup A: Patients with DoC consecutively admitted to participating units and met the inclusion criteria
Trial outcomes
Primary outcomes
1
Clinical Diagnosis
Clinical diagnosis as assessed by the Coma Recovery Scale-Revised (min. - max- score = 0-23, with higher scores indicating a higher level of consciousness)
Time frame
6 months from enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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