Spontaneous Eye Blinking in Disorders of Consciousness

NCT06323031 | Recruiting

• 1 other identifier: Blink-DoC
• Study Type: observational
• Target: 70
• Locations: 4 countries
• Sites: 8

Brief Summary

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

Disorders of Consciousness

Keywords

Disorders of Consciousness; blinking; diagnosis; prognosis; rehabilitation

Outcome Measures

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)

  6 months from enrollment

Study Arms (1)

Patients with DoC consecutively admitted to participating units and met the inclusion criteria

Patients in VS 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.)
• Negative anamnesis for neurological or psychiatric disorders.

You may not qualify if:

• 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).

Sponsors & Collaborators

• 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
• Fondazione Don Carlo Gnocchi ETS: lead

Study Sites (8)

Coma Science Group, GIGA-Consciousness, University of Liege

Liège, Belgium, 4000, Belgium

NOT YET RECRUITING

Therapiezentrum Burgau

Burgau, Germany, 89331, Germany

RECRUITING

Dipartimento di Neurologia, LMU Hospital, LMU Munich

Munich, Germany, 81377, Germany

RECRUITING

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, AV, 83054, Italy

RECRUITING

Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara

Ferrara, Italy, 44124, Italy

RECRUITING

IRCCS Fondazione Don Gnocchi ONLUS

Florence, Italy, 50143, Italy

RECRUITING

IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

Milan, Italy, 20148, Italy

RECRUITING

Instituto de Rehabilitación Neurológica IRENEA

Valencia, Spain, 46007, Spain

RECRUITING

Related Publications (3)

• Wislowska M, Del Giudice R, Lechinger J, Wielek T, Heib DPJ, Pitiot A, Pichler G, Michitsch G, Donis J, Schabus M. Night and day variations of sleep in patients with disorders of consciousness. Sci Rep. 2017 Mar 21;7(1):266. doi: 10.1038/s41598-017-00323-4.

  PMID: 28325926 RESULT

• Barbato G, Ficca G, Muscettola G, Fichele M, Beatrice M, Rinaldi F. Diurnal variation in spontaneous eye-blink rate. Psychiatry Res. 2000 Mar 6;93(2):145-51. doi: 10.1016/s0165-1781(00)00108-6.

  PMID: 10725531 RESULT

• Magliacano A, Rosenfelder M, Hieber N, Bender A, Estraneo A, Trojano L. Spontaneous eye blinking as a diagnostic marker in prolonged disorders of consciousness. Sci Rep. 2021 Nov 17;11(1):22393. doi: 10.1038/s41598-021-01858-3.

  PMID: 34789832 RESULT

MeSH Terms

Conditions

Consciousness Disorders; Disease

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Central Study Contacts

Anna Estraneo, MD

CONTACT

3396418648; aestraneo@dongnocchi.it

Alfonso Magliacano, PhD

CONTACT

3387389414; amagliacano@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion.
• Access Criteria: Upon reasonable request to the study's PI.

Locations

IT (4); DE (2); ES (1); BE (1)