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

NCT06464549 | Active Not Recruiting

• 1 other identifier: SEE-ABI
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Assessment of consciousness and attention in individuals with severe Acquired Brain Injury (sABI) is crucial for planning rehabilitation, but it is often hindered by coexisting sensory-motor and/or cognitive-behavioural disorders. This project aims at evaluating the value of spontaneous eye blinking features to assess patients' attentional abilities and to distinguish patients with unresponsive wakefulness syndrome (UWS) from those in minimally conscious state (MCS). Patients will undergo an EEG-EOG recording at rest and during an auditory oddball task. Eye blinking features on EOG will be analysed and compared to that of healthy individuals. A machine-learning-based algorithm using blinking features for the diagnosis of patients with sABI will be studied and validated preliminarily. This project will help to stratify patients with sABI using easy-to-detect clinical markers, supporting clinicians' decision-making about patient's management. Additionally, blinking patterns related to residual attentional abilities in patients emerged from disorders of consciousness will be investigated.

Conditions

Disorders of Consciousness; Acquired Brain Injury

Keywords

severe acquired brain injury; cognitive rehabilitation; diagnosis; eye blinking; machine learning

Outcome Measures

Primary Outcomes (2)

• Coma Recovery Scale-Revised

  The Coma Recovery Scale-Revised is a clinical scale with a total score ranging from 0 to 23, with higher scores indicating a higher level of consciousness

  Within 2 weeks from study entry

• Levels of Cognitive Functioning

  Levels of Cognitive Functioning is a clinical scale with a score ranging from 1 to 8, with higher scores indicating a higher level of cognitive functioning

  Within 2 weeks from study entry

Study Arms (2)

Patients with severe acquired brain injury

Patients' inclusion criteria: (i) age≥18 years; (ii) time post-injury≥28 days. Exclusion criteria will be: (i) large craniectomy interfering with EEG recording; (ii) unstable clinical conditions; (iii) presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation; (iv) administration of sedative medication in the previous 24h; (v) previous history of neurological or psychiatric diseases; (vi) written informed consent by patient or, where necessary, by primary caregiver.

Diagnostic Test: EEG-EOG recording at rest and during an auditory oddball paradigm

Benchmark sample

i) age≥18 years; ii) normal or corrected-to-normal vision excluding contact lenses; iii) a total score \>22.23 at the Montreal Cognitive Assessment (Santangelo et al., 2015); iv) written informed consent. Exclusion criteria: i) presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation; ii) consumption of drugs acting on the central nervous system; iii) previous history of neurologic or psychiatric diseases.

Diagnostic Test: EEG-EOG recording at rest and during an auditory oddball paradigm

Interventions

EEG-EOG recording at rest and during an auditory oddball paradigm DIAGNOSTIC_TEST

Participants will attend an electroencephalogram-electrooculogram (EEG-EOG) recording session. Eye blinking will be examined during a rest condition (duration: 8 min) and during an active auditory oddball task (duration: 8 min), consisting of randomly intermixed tones (non-target: 500 Hz, overall probability: 80%, n=312; target: 1000 Hz, overall probability: 20%, n=78) presented with a 1-s inter-stimulus interval through headphones.

Benchmark sample; Patients with severe acquired brain injury

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

All patients with sABI consecutively admitted will be screened.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfonso Magliacano: lead

Study Sites (2)

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, AV, 83054, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi Firenze

Florence, Italy

Location

Related Publications (1)

• 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; Brain Injuries; Disease

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: January 13, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

IT (2)