Cross-cultural Adaptation and Multicenter Validation of the Italian Versions of the Brief Evaluation of Receptive Aphasia (BERA) and SWallowing Assessment in Disorders of Consciousness (SWADOC)
Starting soon
Conditions studied: Consciousness Disorders, Severe Acquired Brain Injury
In brief
Patients with severe acquired brain injury may evolve from coma into prolonged disorders of consciousness. In these patients, residual language comprehension and swallowing abilities are difficult to evaluate because standard assessments often depend on verbal or motor responses. The Brief Evaluation of Receptive Aphasia (BERA) assesses receptive language abilities through visual/eye-movement responses, whereas the SWallowing Assessment in Disorders of Consciousness (SWADOC) assesses oral and pharyngeal components of swallowing in patients with disorders of consciousness. This national multicenter observational study aims to perform the Italian cross-cultural adaptation and validation of BERA and SWADOC. Consecutive adult inpatients with severe acquired brain injury and disorders of consciousness will be recruited from four Italian centers. SWADOC will be administered to 57 patients, and BERA will be administered to a nested subgroup of 22 patients who meet additional criteria. Inter-rater reliability, test-retest reliability over 24 hours, and convergent validity with Coma Recovery Scale-Revised scores will be analyzed.
Key facts
- Study ID
- NCT07711119
- Run by
- Alfonso Magliacano
- People needed
- 79
- Starts
- 2026-09-01
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Polo Specialistico Riabilitativo Fondazione Don Gnocchi — Sant'Angelo dei Lombardi, AV, Italy
- IRCCS Fondazione Don Carlo Gnocchi — Florence, Italy
- IRCCS Istituto Neurologico Carlo Besta — Milan, Italy
- IRCCS SM Nascente Fondazione Don Carlo Gnocchi — Milan, Italy
Full record on ClinicalTrials.gov
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