Evaluating eye blinking to assess cognitive abilities in individuals with severe brain injury
Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury
This study is testing if tracking eye blinking can help doctors understand the attention levels of people with severe brain injuries and improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 2 sites (Sant'Angelo dei Lombardi, AV and 1 other locations) |
| Trial ID | NCT06464549 on ClinicalTrials.gov |
What this trial studies
This project evaluates the use of spontaneous eye blinking features to assess attentional abilities in individuals with severe acquired brain injury (sABI). Patients will undergo EEG-EOG recordings at rest and during an auditory oddball task, with eye blinking features analyzed and compared to healthy individuals. A machine-learning algorithm will be developed to assist in diagnosing patients with disorders of consciousness, distinguishing between unresponsive wakefulness syndrome and minimally conscious states. The study aims to provide clinicians with easy-to-detect clinical markers to improve patient management and rehabilitation planning.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with severe acquired brain injury at least 28 days post-injury.
Not a fit: Patients with unstable clinical conditions or those who have significant ophthalmic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of cognitive assessments in patients with severe brain injuries, leading to better rehabilitation strategies.
How similar studies have performed: Previous studies have shown promise in using eye blinking features for cognitive assessment, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of severe acquired brain injury; * age≥18 years; * time post-injury≥28 days * written informed consent by patient or, where necessary, by primary caregiver Exclusion criteria will be: * large craniectomy interfering with EEG recording; * unstable clinical conditions; * presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation; * administration of sedative medication in the previous 24h; * previous history of neurological or psychiatric diseases
Where this trial is running
Sant'Angelo dei Lombardi, AV and 1 other locations
- Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS — Sant'Angelo dei Lombardi, Av, Italy (Recruiting)
- IRCCS Fondazione Don Carlo Gnocchi Firenze — Firenze, Italy (Active_not_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.