Actively Recruiting
Spontaneous Eye Blinking in Disorders of Consciousness
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-09-29
70
Participants Needed
8
Research Sites
61 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
T
Therapiezentrum Burgau
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spontaneous Eye Blinking in Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Disorders of Consciousness (UWS, MCS minus, MCS plus) confirmed by at least four Coma Recovery Scale-Revised (CRS-R) evaluations within a week
- Age 18 years or older
- Time since brain injury onset is 6 months or less
- Previous severe acquired brain injury from any cause (traumatic, vascular, anoxic, mixed, etc.)
- No history of neurological or psychiatric disorders
You will not qualify if you...
- Unstable medical conditions such as respiratory failure, fever, or status epilepticus
- Eye diseases or damage affecting eyelid movement, such as orbital fracture
- Use of sedative drugs within the last 24 hours
- Any new brain injury event after hospital admission, such as stroke
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Coma Science Group, GIGA-Consciousness, University of Liege
Liège, Belgium, Belgium, 4000
Not Yet Recruiting
2
Therapiezentrum Burgau
Burgau, Germany, Germany, 89331
Actively Recruiting
3
Dipartimento di Neurologia, LMU Hospital, LMU Munich
Munich, Germany, Germany, 81377
Actively Recruiting
4
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, AV, Italy, 83054
Actively Recruiting
5
Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara
Ferrara, Italy, Italy, 44124
Actively Recruiting
6
IRCCS Fondazione Don Gnocchi ONLUS
Florence, Italy, Italy, 50143
Actively Recruiting
7
IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS
Milan, Italy, Italy, 20148
Actively Recruiting
8
Instituto de Rehabilitación Neurológica IRENEA
Valencia, Spain, Spain, 46007
Actively Recruiting
Research Team
A
Anna Estraneo, MD
CONTACT
A
Alfonso Magliacano, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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