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Search / Trial NCT06464549

Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury

Launched by ALFONSO MAGLIACANO · Jun 13, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Severe Acquired Brain Injury Cognitive Rehabilitation Diagnosis Eye Blinking Machine Learning

ClinConnect Summary

This clinical trial is studying how eye blinking can help assess attention and consciousness in people who have suffered a severe acquired brain injury (sABI). The goal is to distinguish between those who are in a state of unresponsive wakefulness and those who show some signs of consciousness. By analyzing eye blinks using special equipment, researchers hope to find patterns that can indicate a patient’s cognitive abilities, which will assist doctors in planning better rehabilitation strategies.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with severe brain injury for at least 28 days. Participants will undergo a simple test where their brain and eye activity will be recorded while they are resting and during a listening task. It’s important to note that certain conditions, such as recent major surgery on the brain or the use of sedative medication, may exclude someone from joining the trial. The findings from this research could lead to new ways of understanding and treating patients with disorders of consciousness.

Gender

ALL

Eligibility 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

About Alfonso Magliacano

Alfonso Magliacano is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, Magliacano leads a team of experts in the design, implementation, and management of clinical trials across various phases and therapeutic areas. Emphasizing rigorous adherence to regulatory standards and ethical practices, the organization collaborates with healthcare professionals and research institutions to ensure the highest quality of data and patient safety. By fostering partnerships and embracing cutting-edge methodologies, Alfonso Magliacano strives to contribute significantly to the medical community and enhance the quality of care for patients worldwide.

Locations

Firenze, , Italy

Sant'angelo Dei Lombardi, Av, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported