DysphagiaSCALA_DISFNCT07503145
Translation and Validation of a Swallowing Assessment Scale for Neurogenic Dysphagia
An observational study of Dysphagia, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Clinical assessment tool
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2022to 22 May 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with dysphagia due to neurological aetiology (stroke, PD, multiple sclerosis, amyotrophic lateral sclerosis, , cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumour or traumatic brain injury)
Who may be able to join
- Neurological etiology including stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumor, or traumatic brain injury Diagnosed oropharyngeal dysphagia (OD) confirmed by a neurologist Age ≥ 18 years
Who cannot join
- Inability to maintain a stable sitting position during endoscopy Contraindications to Fiberoptic Endoscopic Evaluation of Swallowing (FEES), including fever or agitation that compromises participation
Trial locations and contacts
1 site in 1 country.
About this study
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Validating the MUCSS in Italian would aid in better managing neurogenic dysphagia patients.
Read the detailed description
Neurogenic dysphagia is a swallowing disorder resulting from neurological diseases, primarily characterized by alterations in the oral and pharyngeal phases. Neurogenic dysphagia is a very common disorder, affecting 40-70% of individuals who have had a stroke and 60-80% of those with neurodegenerative diseases in Physical Medicine and Rehabilitation and Neurorehabilitation settings. The main complications of dysphagia are aspiration pneumonia, malnutrition, and dehydration, which can worsen the clinical picture and compromise the patient's quality of life. To identify swallowing disorders early and prevent complications, it is recommended to use standardized screening protocols and clinical evaluation by a speech therapist. If clinical questions remain, further investigation with instrumental exams such as videofluoroscopy (VFS) and/or fibroscopy is indicated. Within clinical evaluation, it is advisable to use outcome scales to objectively determine the severity of the disorder, describe the functional level of swallowing abilities, and monitor the evolution of the function over time.
The Munich Swallowing Score (MUCSS) [Bartolome G, 2021] is a clinical tool used to assess the functional level of saliva/secretions, liquids, and food swallowing. It consists of two scales, each with eight levels: the Munich Swallowing Score-Saliva (MUCSS-S), which evaluates the management of saliva/secretions, and the Munich Swallowing Score-Nutrition (MUCSS-N), which focuses on nutrition.
In the literature, the assessment of saliva/secretions management is still insufficiently explored. Difficulties in swallowing and managing saliva/secretions significantly affect the clinical progress of the patient and their quality of life. In this sense, a scale that considers both saliva/secretions swallowing and the presence of a cannula, in addition to liquid/food swallowing, represents an innovative and useful tool in clinical practice.
The MUCSS is a scale sensitive to the evolution of swallowing abilities, allowing an objective and repeatable evaluation of the management of secretions as well. The translation into Italian and validation of the MUCSS scale would provide an important contribution to the assessment and, consequently, the management of patients with neurogenic dysphagia.
- Conditions
- Dysphagia
- Being tested
- Clinical assessment tool
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessment toolOther
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. It is an important outcome to consider the presence of a tracheostomy tube and the management of secretions in relation to nutritional methods.
| Study group | Role | What they receive |
|---|---|---|
| patients with neurogenic dysphagia | Patients with neurogenic dysphagia of different etiologies (Parkinson's disease, ALS, MS, stroke, traumatic brain injury, severe acquired brain injury)." Receives: Other: Clinical assessment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of tracheostomy tube and secretion management status
Assessment of tracheostomy tube presence and secretion management in relation to nutritional modality (oral vs non-oral feeding).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start12 May 2022
- Primary completion3 Dec 2024
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Nordio, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503145
- Sponsor's protocol ID
- 2022.03
- Acronym
- SCALA_DISF
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of a Swallowing Assessment Scale for Neurogenic Dysphagia
- ClinicalTrials.gov ID
- NCT07503145
- Acronym / sponsor ID
- SCALA_DISF / 2022.03
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 31 Mar 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.
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Validating the MUCSS in Italian would aid in better managing neurogenic dysphagia patients.
Detailed description
Neurogenic dysphagia is a swallowing disorder resulting from neurological diseases, primarily characterized by alterations in the oral and pharyngeal phases. Neurogenic dysphagia is a very common disorder, affecting 40-70% of individuals who have had a stroke and 60-80% of those with neurodegenerative diseases in Physical Medicine and Rehabilitation and Neurorehabilitation settings. The main complications of dysphagia are aspiration pneumonia, malnutrition, and dehydration, which can worsen the clinical picture and compromise the patient's quality of life. To identify swallowing disorders early and prevent complications, it is recommended to use standardized screening protocols and clinical evaluation by a speech therapist. If clinical questions remain, further investigation with instrumental exams such as videofluoroscopy (VFS) and/or fibroscopy is indicated. Within clinical evaluation, it is advisable to use outcome scales to objectively determine the severity of the disorder, describe the functional level of swallowing abilities, and monitor the evolution of the function over time.
The Munich Swallowing Score (MUCSS) [Bartolome G, 2021] is a clinical tool used to assess the functional level of saliva/secretions, liquids, and food swallowing. It consists of two scales, each with eight levels: the Munich Swallowing Score-Saliva (MUCSS-S), which evaluates the management of saliva/secretions, and the Munich Swallowing Score-Nutrition (MUCSS-N), which focuses on nutrition.
In the literature, the assessment of saliva/secretions management is still insufficiently explored. Difficulties in swallowing and managing saliva/secretions significantly affect the clinical progress of the patient and their quality of life. In this sense, a scale that considers both saliva/secretions swallowing and the presence of a cannula, in addition to liquid/food swallowing, represents an innovative and useful tool in clinical practice.
The MUCSS is a scale sensitive to the evolution of swallowing abilities, allowing an objective and repeatable evaluation of the management of secretions as well. The translation into Italian and validation of the MUCSS scale would provide an important contribution to the assessment and, consequently, the management of patients with neurogenic dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with neurogenic dysphagia | – | Other: Clinical assessment toolPatients with neurogenic dysphagia of different etiologies (Parkinson's disease, ALS, MS, stroke, traumatic brain injury, severe acquired brain injury)." |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with dysphagia due to neurological aetiology (stroke, PD, multiple sclerosis, amyotrophic lateral sclerosis, , cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumour or traumatic brain injury)
Key inclusion criteria (1 listed)
- Neurological etiology including stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumor, or traumatic brain injury Diagnosed oropharyngeal dysphagia (OD) confirmed by a neurologist Age ≥ 18 years
Key exclusion criteria (1 listed)
- Inability to maintain a stable sitting position during endoscopy Contraindications to Fiberoptic Endoscopic Evaluation of Swallowing (FEES), including fever or agitation that compromises participation
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 |
|---|---|---|
| Clinical assessment toolThe Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. It is an important outcome to consider the presence of a tracheostomy tube and the management of secretions in relation to nutritional methods. | Other | patients with neurogenic dysphagia |
Primary outcome
Presence of tracheostomy tube and secretion management status
Time frame: 7 days
Assessment of tracheostomy tube presence and secretion management in relation to nutritional modality (oral vs non-oral feeding).
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by IRCCS San Camillo, Venezia, Italy at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of tracheostomy tube and secretion management status (time frame: 7 days). 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 22 Apr 2026.