Night and day variations of sleep in patients with disorders of consciousness.
Malgorzata Wislowska, Renata Del Giudice, Julia Lechinger...
https://pubmed.ncbi.nlm.nih.gov/28325926Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06323031
Spontaneous Eye Blinking as a Diagnostic and Prognostic Marker in Patients With Disorders of Consciousness After Severe Acquired Brain Injury
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-09-29
70
Participants Needed
8
Research Sites
17 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
Researchers are investigating the use of spontaneous eye blinking features, such as rate, amplitude, duration, and variability, to improve the diagnosis and prognosis of patients with Disorders of Consciousness (DoC) following Severe Acquired Brain Injury (sABI). The study focuses on differentiating between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), which is challenging due to severe cognitive and sensorimotor impairments. This multicenter, prospective observational study involves patients admitted to eight European centers and aims to enroll 70 patients alongside 23 healthy volunteers as a comparison group. Patients diagnosed with DoC after sABI will undergo two 20-minute resting electroencephalogram-electrooculogram (EEG-EOG) recordings within two weeks of study entry, spaced 24 hours apart. These sessions take place with patients awake, eyes open, in a calm environment, with procedures to encourage arousal if needed. Eye blinks are monitored via EOG, and the level of consciousness is assessed with the Coma Recovery Scale-Revised (CRS-R) at each session. Follow-up assessment is scheduled six months after enrollment. Healthy volunteers will also complete two similar EEG-EOG sessions. Participants' involvement includes EEG and EOG monitoring with electrodes placed on the scalp and around the eyes, following standard protocols to ensure data quality. Clinical evaluations using CRS-R occur alongside blink recordings. Data analysis will compare blink features across diagnostic groups and over time, exploring their relationship with consciousness levels. The main outcome measured at six months is the clinical diagnosis. The study duration is approximately 24 months, including enrollment and follow-up phases.
CONDITIONS
Brief Title
Spontaneous Eye Blinking in Disorders of Consciousness
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Disorders of Consciousness (UWS, MCS minus, MCS plus) confirmed by repeated evaluations
- Age 18 years or older
- Time since brain injury is 6 months or less
- Severe acquired brain injury of any cause (traumatic, vascular, anoxic, mixed, etc.)
- No history of neurological or psychiatric disorders
You will not qualify if you...
- Unstable clinical conditions such as respiratory failure, fever, or status epilepticus
- Eye or eyelid movement disorders, including orbital fracture
- Use of sedative drugs within 24 hours before study procedures
- Additional brain injury event after study admission, such as stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits (in-person) within two weeks for EEG-EOG sessions
Monitoring
Duration - Within two weeks from study entry
Participants undergo two 20-minute resting EEG-EOG examinations to evaluate spontaneous eye blinking and level of consciousness. These recordings are performed at the bedside or on a wheelchair with the patient awake. The Coma Recovery Scale-Revised is administered at the end of each session.
2 visits (in-person) 24 hours apart
Long-term Monitoring
Duration - 6 months from enrollment
Participants are assessed at 6 months from enrollment to evaluate clinical diagnosis and outcomes related to eye blink features and level of consciousness.
1 follow-up visit (in-person)
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
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Research Team
A
Anna Estraneo, MD
A
Alfonso Magliacano, PhD
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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Published Research Related To This Trial
Diurnal variation in spontaneous eye-blink rate.
G Barbato, G Ficca, G Muscettola...
https://pubmed.ncbi.nlm.nih.gov/10725531Spontaneous eye blinking as a diagnostic marker in prolonged disorders of consciousness.
Alfonso Magliacano, Martin Rosenfelder, Nina Hieber...
https://pubmed.ncbi.nlm.nih.gov/34789832