Blink of an eye: new study uses eye movements to assess brain injury patients

NCT ID NCT06464549

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks at whether spontaneous eye blinking can help doctors understand the level of consciousness and attention in people with severe acquired brain injury. Researchers will record eye blinks using simple sensors while patients rest or listen to sounds. The goal is to develop a tool that helps tell apart patients who are unaware from those who show minimal signs of awareness, aiding in rehabilitation planning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

44 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients with sABI consecutively admitted will be screened.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain injury Consciousness Disorders disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • IRCCS Fondazione Don Carlo Gnocchi Firenze

    Florence, Italy

  • Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

    Sant'Angelo dei Lombardi, AV, 83054, Italy

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