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Spontaneous Eye Blinking in Disorders of Consciousness

NCT06323031 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-09-29

No results posted yet for this study

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

Sponsors & Collaborators

  • Therapiezentrum Burgau

    collaborator OTHER

  • University of Liege

    collaborator OTHER

  • University Hospital Munich

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • VITHAS Valencia (Spain)

    collaborator UNKNOWN

  • Lavezzi Susanna, Local Health Unit, Ferrara (IT)

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • Belgium
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06323031 on ClinicalTrials.gov