NCT06323031 Spontaneous Eye Blinking in Disorders of Consciousness
| NCT ID | NCT06323031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Disorders of Consciousness |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2025-05-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06323031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disorders of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06323031 currently recruiting?
Yes, NCT06323031 is actively recruiting participants. Contact the research team at aestraneo@dongnocchi.it for enrollment information.
Where is the NCT06323031 trial being conducted?
This trial is being conducted at Liège, Belgium, Burgau, Germany, Munich, Germany, Sant'Angelo dei Lombardi, Italy and 4 additional locations.
Who is sponsoring the NCT06323031 clinical trial?
NCT06323031 is sponsored by Fondazione Don Carlo Gnocchi ETS. The trial plans to enroll 70 participants.