Cure My Disease

Don't miss your cure!

 Log in / Sign up

New italian tools could unlock communication and swallowing assessment in brain injury patients

NCT ID NCT07711119

Diagnosis Sponsor: Alfonso Magliacano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study adapts and validates Italian versions of two clinical scales for patients with disorders of consciousness after severe brain injury. The Brief Evaluation of Receptive Aphasia (BERA) assesses language understanding using eye movements, and the SWallowing Assessment in Disorders of Consciousness (SWADOC) evaluates swallowing ability. Researchers will test these scales in 79 patients across four Italian centers to ensure they are reliable and accurate for Italian-speaking patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, Italian clinicians will have reliable tools to evaluate language comprehension and swallowing in patients who cannot speak or move, improving care and communication.
What could go wrong
This is an observational validation study with a small sample (79 patients), so results may not generalize widely. The scales are new to Italian, and reliability depends on consistent administration.

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

About 79 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

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

Adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness consecutively admitted to the four participating Italian rehabilitation/neurorehabilitation centers and meeting the inclusion/exclusion criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age \>= 18 years. * Native Italian speaker. * Diagnosis of severe acquired brain injury. * At least 28 days since the acute event. * For SWADOC validation: stable clinical diagnosis of disorder of consciousness, including UWS, MCS, or EMCS, assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks. * For BERA validation: stable clinical diagnosis of MCS or EMCS assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks. * For BERA validation: presence of visual fixation and/or visual pursuit assessed with the Coma Recovery Scale-Revised. * No remote history of neurological, neurodegenerative, or psychiatric disease; for SWADOC validation, no remote history of otorhinolaryngological disease. * Written informed consent provided by the primary caregiver/legal representative according to local regulations. Exclusion Criteria: * Occurrence of a second cerebral event between enrollment and data collection. * Unstable general clinical condition preventing assessment, including but not limited to need for ventilatory support, severe infection, or status epilepticus.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Consciousness disorders are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Aphasia, Wernicke brain injury Consciousness Disorders

As listed by the trial registrant

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

Consciousness disorders Severe acquired brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Fondazione Don Carlo Gnocchi

    Florence, Italy

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Italy

  • IRCCS SM Nascente Fondazione Don Carlo Gnocchi

    Milan, Italy

  • Polo Specialistico Riabilitativo Fondazione Don Gnocchi

    Sant'Angelo dei Lombardi, AV, 83054, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.