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)

ClinicalTrials.gov ID

NCT07711119

Lead Sponsor

Alfonso MagliacanoOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

79Estimated

Last Update Posted

Jul 17, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

Aug 31, 2028Estimated

Official Title

Adattamento Trans-culturale e Validazione Multicentrica Della Versione Italiana Delle Scale Brief Evaluation of Receptive Aphasia (BERA) e SWallowing Assessment in Disorders of Consciousness (SWADOC)

Brief Summary

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.

Detailed Description

This study is part of the Horizon MSCA DoC-Box project, which aims to develop a multimodal toolbox to support fast and reliable diagnosis of disorders of consciousness. The study includes two consecutive phases. In Phase 1, the original French versions of BERA and SWADOC will be translated into Italian by two expert translators. The translated versions will be synthesized, back-translated into the original language by two independent blinded translators, compared, discussed, and revised by researchers and experts according to international guidelines for translation and cultural adaptation. In Phase 2, the Italian versions will be evaluated in a multicenter observational validation study involving three Fondazione Don Carlo Gnocchi centers (Sant'Angelo dei Lombardi, Florence, Milan) and the IRCCS Istituto Neurologico Carlo Besta in Milan. After diagnostic confirmation based on repeated CRS-R assessments, Examiner A will administer the SECONDs to assess the level of consciousness. On the same day, Examiner B will administer the Italian BERA and/or SWADOC, while Examiner C will independently score the scales to assess inter-rater agreement. After approximately 24 hours, Examiner A will repeat the SECONDs, and either Examiner B or Examiner C will repeat BERA and/or SWADOC to assess test-retest reliability. Demographic and clinical variables, level of consciousness, total scores, and subscale scores will be entered in a centralized pseudonymized REDCap database and analyzed in aggregate form.

• Consciousness Disorders
• Severe Acquired Brain Injury

• Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)
• Italian Brief Evaluation of Receptive Aphasia (BERA)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Alfonso MagliacanoOTHER

Collaborators

Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaOTHER

bhakiki@dongnocchi.it3905573931

Matilde.Leonardi@istituto-besta.it390223941

acomanducci@dongnocchi.it3902403081

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