Consciousness DisordersNCT07711119
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)
An observational study of Consciousness Disorders and Severe Acquired Brain Injury, run by Alfonso Magliacano at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consciousness Disorders, Severe Acquired Brain Injury
- What is being tested?
- Italian SWallowing Assessment in Disorders of Consciousness (SWADOC) and Italian Brief Evaluation of Receptive Aphasia (BERA)
- Type of treatment
- Pill or oral medicine
- How many people
- 79 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Estraneo, MD contact
Italy4 sites
IRCCS Fondazione Don Carlo Gnocchi
Florence
Bahia Hakiki, 3905573931, bhakiki@dongnocchi.it
IRCCS Istituto Neurologico Carlo Besta
Milan
Matilde Leonardi, 390223941, Matilde.Leonardi@istituto-besta.it
IRCCS SM Nascente Fondazione Don Carlo Gnocchi
Milan
Angela Comanducci, 3902403081, acomanducci@dongnocchi.it
Polo Specialistico Riabilitativo Fondazione Don Gnocchi
Sant'Angelo dei Lombardi, AV, 83054
Alfonso Magliacano, 393387389414, amagliacano@dongnocchi.it
About this study
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)
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.
Read the 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.
- Being tested
- Italian SWallowing Assessment in Disorders of Consciousness (SWADOC), Italian Brief Evaluation of Receptive Aphasia (BERA)
- Keywords
- disorders of consciousness, severe acquired brain injury, BERA, Brief Evaluation of Receptive Aphasia, SWADOC, swallowing assessment, Receptive Aphasia, rehabilitation
- Medical subject headings
- Consciousness Disorders, Brain Injuries, Aphasia, Wernicke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)Diagnostic test
Structured clinical assessment of oral and pharyngeal swallowing components in patients with disorders of consciousness. The Italian version will be administered and scored by trained examiners to evaluate inter-rater and test-retest reliability.
Italian Brief Evaluation of Receptive Aphasia (BERA)Diagnostic test
Brief clinical assessment of receptive language abilities, including phonology, semantics, and morphosyntax. Responses are based on visual/eye-movement behavior, allowing assessment of patients unable to communicate verbally or through reliable motor responses. It will be administered to the nested subgroup meeting BERA-specific criteria.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe acquired brain injury and disorders of consciousness | Consecutive adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness admitted to one of the four participating centers and meeting eligibility criteria. All eligible participants will undergo SWADOC validation assessments. A nested subgroup of the first 22 participants who also meet BERA-specific criteria will undergo BERA validation assessments. Receives: Diagnostic Test: Italian SWallowing Assessment in Disorders of Consciousness (SWADOC); Diagnostic Test: Italian Brief Evaluation of Receptive Aphasia (BERA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
Inter-rater reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The SWADOC quantitative scoring system includes 8 scored items rated from 0 to 3, allowing calculation of oral and pharyngeal subscores and a total score.
Measured: Day 1, during the first assessment session
Test-retest reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
Test-retest reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.
Measured: Baseline and approximately 24 hours later
Inter-rater reliability of the Italian Brief Evaluation of Receptive Aphasia total score
Inter-rater reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The BERA includes 30 items per version, with 10 phonological, 10 semantic, and 10 morphosyntactic items; each correct visual fixation response is scored as 1 point and errors or absent fixation as 0 points.
Measured: Day 1, during the first assessment session
Test-retest reliability of the Italian Brief Evaluation of Receptive Aphasia total score
Test-retest reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.
Measured: Baseline and approximately 24 hours later
Secondary outcomes (2)
Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score
Convergent validity will be assessed by calculating the Spearman rank correlation coefficient between the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness and the total score of the Coma Recovery Scale-Revised. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The Coma Recovery Scale-Revised total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness. The reported outcome will be Spearman's rho, a unitless correlation coefficient ranging from -1 to +1.
Measured: Baseline/Day 1
Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score
Convergent validity will be assessed by calculating the Spearman rank correlation coefficient between the total score of the Italian version of the Brief Evaluation of Receptive Aphasia and the total score of the Coma Recovery Scale-Revised. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The Coma Recovery Scale-Revised total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness. The reported outcome will be Spearman's rho, a unitless correlation coefficient ranging from -1 to +1.
Measured: Baseline/Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfonso Magliacano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alfonso Magliacano, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Alfonso Magliacano, PhD, Principal investigator, Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711119
- Sponsor's protocol ID
- BERA-SWADOC
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07711119
- Acronym / sponsor ID
- BERA-SWADOC
- Keywords
- disorders of consciousness, severe acquired brain injury, BERA, Brief Evaluation of Receptive Aphasia, SWADOC, swallowing assessment, Receptive Aphasia, rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Alfonso MagliacanoUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe acquired brain injury and disorders of consciousness | – | Diagnostic Test: Italian SWallowing Assessment in Disorders of Consciousness (SWADOC), Diagnostic Test: Italian Brief Evaluation of Receptive Aphasia (BERA)Consecutive adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness admitted to one of the four participating centers and meeting eligibility criteria. All eligible participants will undergo SWADOC validation assessments. A nested subgroup of the first 22 participants who also meet BERA-specific criteria will undergo BERA validation assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)Structured clinical assessment of oral and pharyngeal swallowing components in patients with disorders of consciousness. The Italian version will be administered and scored by trained examiners to evaluate inter-rater and test-retest reliability. | Diagnostic test | Patients with severe acquired brain injury and disorders of consciousness |
| Italian Brief Evaluation of Receptive Aphasia (BERA)Brief clinical assessment of receptive language abilities, including phonology, semantics, and morphosyntax. Responses are based on visual/eye-movement behavior, allowing assessment of patients unable to communicate verbally or through reliable motor responses. It will be administered to the nested subgroup meeting BERA-specific criteria. | Diagnostic test | Patients with severe acquired brain injury and disorders of consciousness |
Primary outcome
Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
Time frame: Day 1, during the first assessment session
Inter-rater reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The SWADOC quantitative scoring system includes 8 scored items rated from 0 to 3, allowing calculation of oral and pharyngeal subscores and a total score.
Test-retest reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
Time frame: Baseline and approximately 24 hours later
Test-retest reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.
Inter-rater reliability of the Italian Brief Evaluation of Receptive Aphasia total score
Time frame: Day 1, during the first assessment session
Inter-rater reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The BERA includes 30 items per version, with 10 phonological, 10 semantic, and 10 morphosyntactic items; each correct visual fixation response is scored as 1 point and errors or absent fixation as 0 points.
Test-retest reliability of the Italian Brief Evaluation of Receptive Aphasia total score
Time frame: Baseline and approximately 24 hours later
Test-retest reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.
2 secondary outcomes
Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score
Time frame: Baseline/Day 1
Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score
Time frame: Baseline/Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Estraneo, MD contact
Alfonso Magliacano, PhD principal investigator
Fondazione Don Carlo Gnocchi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorders and Severe Acquired Brain Injury, run by Alfonso Magliacano at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Magliacano, PhD (393387389414, amagliacano@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score (time frame: Day 1, during the first assessment session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.