PARKINSON DISEASE (Disorder)NCT07356414
SwallowFIT Study in Parkinson's Disease
A study testing SwallowFit in people with PARKINSON DISEASE (Disorder), run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease. The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- SwallowFit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 29 Jun 2028
- Phase
- Interventional
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult S-VWP between >35-90 years of age
- Diagnosis of Idiopathic Parkinson's Disease [IDP] (either or suspected, tremor-predominant or rigid predominant)
- Disability level of Hoehn \& Yahr stages II-III as indicated in their most recent neurological evaluation
- Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale [MDS-UPDRS]-
- ADL swallowing item >0, or Mann Assessment of Swallowing scale [MASA] score ≤185.
- Able to consume oral nutrition [Functional Oral Intake Score ≤ 6]
- Ambulatory
- No change of medication for at least 4 weeks before study inclusion
Who cannot join
- Classified as Hoehn and Yahr stages IV
- Unable to follow 2 step commands
- History of other neurological disease potentially causing dysphagia
- Dementia (MMSE<20; Montreal cognitive assessment (MoCA) ≤ 20)
- Severe depression (BDI>19)
- Severe dyskinesia of head and neck (resulting in problems with MBSS recording)
Show all 14Show fewer
- Severe documented Gastrointestinal disease
- History of Gastro-esophageal surgery
- History of Head or neck cancer with swallowing impairment or surgical intervention
- History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.
- Untreated hypertension
- Heart disease requiring restricted activity and medical intervention
- Speech therapy intervention for swallowing within the past three months
- Women who are pregnant, nursing, or who plan to become pregnant during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brooke Army Medical Center (BAMC)
San Antonio, Texas, 78234-6200
Giselle Carnaby, PhD, MPH, 210-450-7130, carnaby@uthscsa.edu
Alexis Nelson, 210-916-2203.
About this study
Official title: "SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.
The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.
The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.
Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.
Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
Read the detailed description
SwallowFIT: Subjects will receive 6-weeks of twice weekly SwallowFIT intervention per protocol (1-hour session each visit) from the BAMC speech language Pathologist (study SLP) at BAMC. Completion of the program will include 12 visits. The program is designed from a previous successful pilot trial. It begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites.
Following this the program trains a modified effortful swallow technique at its onset using sEMG to guide the development of better swallow movement form, effort and performance. Once swallowing form is established, the program uses a hierarchy of swallowing tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
Clinical Monitoring Only (CMO): This intervention mirrors the experimental intervention in all aspects, but the treatment type applied. CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only once an obvious issue has been identified.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- SwallowFit
- Keywords
- Swallowing, US Service members, Veterans, SwallowFIT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwallowFitBehavioural
Also called Swallowing exercises
The SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations.
| Study group | Role | What they receive |
|---|---|---|
| SwallowFit Intervention | Experimental | Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions. Receives: Behavioral: SwallowFit |
| Clinical Monitoring Only (CMO) | No intervention | CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mann Assessment of Swallowing Ability (MASA)
The MASA score is measured using a 5-point to 10-point rating scale. The total possible score of the MASA is 200 points, and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).
Measured: Baseline to 6 months
Modified Unified Parkinson Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS uses a 0-4 scoring system, with higher scores indicating more severe symptoms. Parts I-III are scored on a 0-4 scale, while Part IV uses "yes" and "no" ratings. The total score range is 0-260, with 0 representing no disability and 260 representing total disability.
Measured: Baseline to 6 months
Modified Hoehn and Yahr (HY) Scale
The Hoehn and Yahr (H\&Y) scale is a grading system used to assess the progression and severity of motor symptoms in Parkinson's disease (PD). It ranges from Stage 0 (no signs of disease) to Stage 5 (severe disability, wheelchair or bed bound). Stages 1, 1.5, 2, and 2.5 are considered early stages, while stages 3, 4, and 5 represent later, more advanced stages.
Measured: Baseline to 6 months
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a maximum score of 30 points, with a score of 26 or higher generally indicating normal cognitive function. Scores between 18 and 25 may suggest mild cognitive impairment (MCI), while scores below 18 may indicate moderate to severe impairment.
Measured: Baseline to 6 months
PD Quality of Life Scale (PDQ-39)
The PDQ-39 is a questionnaire used to assess the impact of Parkinson's disease on quality of life. It consists of 39 questions, each rated on a 5-point scale from 0 (never) to 4 (always). Scores for the 39 questions are added to obtain a total score.
The scores for the 8 subscales (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort) are obtained by summing the scores for the relevant questions within each subscale.
The total score and subscale scores range from 0 to 100, with higher scores indicating a greater impact of Parkinson's disease on quality of life.
Measured: Baseline to 6 months
Secondary outcomes (10)
Modified Barium Swallowing Impairment Profile, overall impression score (MBSImp OI score)
In the context of the Modified Barium Swallow Impairment Profile (MBSImP), Overall Impression (OI) scoring is the most common method used to assess swallowing physiology. It involves assigning a score to each of the 17 physiological components based on the most severe impairment observed across different swallowing tasks. These scores range from 0 to 4 depending on the component, and total scores range from 0-68 with higher scores indicating greater impairment.
Measured: Baseline to 6 months
Spontaneous Swallowing Frequency (SSF)
Spontaneous swallowing frequency (SSF) scoring refers to counting the number of times a person swallows without any specific prompting or external stimuli. It's a method used to assess swallowing function, particularly in conditions like dysphagia (difficulty swallowing), and can be a tool for screening and evaluating swallowing problems. A 5-10 minute sampling window is often used to calculate SSF.
Healthy Swallowing:
In healthy individuals, spontaneous swallowing typically occurs at a rate of 1-2 swallows per minute.
Dysphagia:
Patients with dysphagia often have a reduced SSF compared to healthy individuals.
Thresholds:
Some studies have suggested a threshold of 0.40 swallows per minute as a potential indicator of significant dysphagia.
Measured: Baseline to 6 months
Penetration Aspiration Scale (PAS)
The Penetration-Aspiration Scale (PAS) is an 8-point scale used to assess the depth and response to airway invasion during swallowing. It helps clinicians and researchers understand the severity of swallowing dysfunction by categorizing the location of the bolus within the airway and whether it's expelled or not. The scale is used in videofluoroscopic swallowing studies (VFSS) to quantify swallowing event. A score of 1 would indicate no material entered the airway while a score of 8 would indicate the most amount of material aspirated during swallowing.
Measured: Baseline to 6 months
Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT)
Method of measuring physiologic kinematics and timing for swallowing images retrieved from modified barium swallow (MBSS). It evaluates of 8 key parameters of swallowing taken by frame analysis on open-source NIH, Image J software. Scoring of kinematic swallow movements will be evaluated using the published protocol
Measured: Baseline to 6 months
Functional Oral Intake Scale (FOIS)
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess a patient's ability to swallow and eat safely and efficiently. Scores range from 1 to 7, with higher scores indicating better swallowing function and a greater ability to participate in oral intake.
Measured: Baseline to 6 months
Lingual Pressure/movement
The Lingual Pressure Movement Scale, part of the AIMS (Abnormal Involuntary Movement Scale), assesses the severity of tongue movements. It uses a 0-4 scale, where 0 represents no movement, 1 represents minimal movement (may be extreme normal), 2 represents mild movement, 3 represents moderate movement, and 4 represents severe movement.
Measured: Baseline to 6 months
Sydney Swallowing Questionnaire (SSQ)
The Sydney Swallow Questionnaire (SSQ) is scored by summing the individual scores for each question. It consists of 17 questions, with most questions scored on a visual analog scale (VAS), ranging from 0 to 100 mm. The total possible score is 1700. Higher scores indicate more severe swallowing difficulties.
Measured: Baseline to 6 months
Protocol Adherence Measure
Percentage attendance measured by number of prescribed exercise sessions completed
Measured: Baseline to 6 months
Patient Perception of Swallowing (VAS)
In patient perception of swallowing, a Visual Analogue Scale (VAS) is used to assess a patient's subjective experience of swallowing difficulties. Patients mark a point on a line (typically 100 mm) that represents the severity of their swallowing problem, with 0 indicating no trouble and 100 indicating a total inability to swallow.
Measured: Baseline to 6 months
Patient/Caregiver Acceptability/Satisfaction Scale (PA/SS)
A 5 item scale where each item is scored on a Likert scale from 0-10. Total scores range from 0-50 with a higher score indicating that the SwallowFIT program was more helpful.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single site, double blind randomized controlled trial comparing a proactive swallow exercise intervention to a control group receiving clinical monitoring only (or CMO).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Giselle Carnaby, PhD, MP, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356414
- Sponsor's protocol ID
- STUDY00001444
- Other IDs
- FY24 HT942524PRPIIRA
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will report and publish in a peer-reviewed journal (trials journal) the study protocol and proposed analysis, to provide similar information to the national and international scientific community. Information provision and awareness-raising will take place during project inception and intensify as results become available. Study results will be published and displayed on the project webpage following completion of the 6 month follow up of all subjects.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07356414
- Acronym / sponsor ID
- STUDY00001444
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Swallowing, US Service members, Veterans, SwallowFIT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 21 Jan 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 goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.
The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.
Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.
Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
Detailed description
SwallowFIT: Subjects will receive 6-weeks of twice weekly SwallowFIT intervention per protocol (1-hour session each visit) from the BAMC speech language Pathologist (study SLP) at BAMC. Completion of the program will include 12 visits. The program is designed from a previous successful pilot trial. It begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites.
Following this the program trains a modified effortful swallow technique at its onset using sEMG to guide the development of better swallow movement form, effort and performance. Once swallowing form is established, the program uses a hierarchy of swallowing tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.
Clinical Monitoring Only (CMO): This intervention mirrors the experimental intervention in all aspects, but the treatment type applied. CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only once an obvious issue has been identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single site, double blind randomized controlled trial comparing a proactive swallow exercise intervention to a control group receiving clinical monitoring only (or CMO).
| Arm | Type | Receives |
|---|---|---|
| SwallowFit Intervention | Experimental | Behavioral: SwallowFitSubjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions. |
| Clinical Monitoring Only (CMO) | No intervention | –CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult S-VWP between >35-90 years of age
- Diagnosis of Idiopathic Parkinson's Disease [IDP] (either or suspected, tremor-predominant or rigid predominant)
- Disability level of Hoehn \& Yahr stages II-III as indicated in their most recent neurological evaluation
- Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale [MDS-UPDRS]-
- ADL swallowing item >0, or Mann Assessment of Swallowing scale [MASA] score ≤185.
Key exclusion criteria (14 listed)
- Classified as Hoehn and Yahr stages IV
- Unable to follow 2 step commands
- History of other neurological disease potentially causing dysphagia
- Dementia (MMSE<20; Montreal cognitive assessment (MoCA) ≤ 20)
- Severe depression (BDI>19)
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 |
|---|---|---|
| SwallowFitAlso: Swallowing exercisesThe SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations. | Behavioural | SwallowFit Intervention |
Primary outcome
Mann Assessment of Swallowing Ability (MASA)
Time frame: Baseline to 6 months
The MASA score is measured using a 5-point to 10-point rating scale. The total possible score of the MASA is 200 points, and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).
Modified Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to 6 months
The MDS-UPDRS uses a 0-4 scoring system, with higher scores indicating more severe symptoms. Parts I-III are scored on a 0-4 scale, while Part IV uses "yes" and "no" ratings. The total score range is 0-260, with 0 representing no disability and 260 representing total disability.
Modified Hoehn and Yahr (HY) Scale
Time frame: Baseline to 6 months
The Hoehn and Yahr (H\&Y) scale is a grading system used to assess the progression and severity of motor symptoms in Parkinson's disease (PD). It ranges from Stage 0 (no signs of disease) to Stage 5 (severe disability, wheelchair or bed bound). Stages 1, 1.5, 2, and 2.5 are considered early stages, while stages 3, 4, and 5 represent later, more advanced stages.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to 6 months
The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a maximum score of 30 points, with a score of 26 or higher generally indicating normal cognitive function. Scores between 18 and 25 may suggest mild cognitive impairment (MCI), while scores below 18 may indicate moderate to severe impairment.
PD Quality of Life Scale (PDQ-39)
Time frame: Baseline to 6 months
The PDQ-39 is a questionnaire used to assess the impact of Parkinson's disease on quality of life. It consists of 39 questions, each rated on a 5-point scale from 0 (never) to 4 (always). Scores for the 39 questions are added to obtain a total score. The scores for the 8 subscales (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort) are obtained by summing the scores for the relevant questions within each subscale. The total score and subscale scores range from 0 to 100, with higher scores indicating a greater impact of Parkinson's disease on quality of life.
10 secondary outcomes
Modified Barium Swallowing Impairment Profile, overall impression score (MBSImp OI score)
Time frame: Baseline to 6 months
Spontaneous Swallowing Frequency (SSF)
Time frame: Baseline to 6 months
Penetration Aspiration Scale (PAS)
Time frame: Baseline to 6 months
Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT)
Time frame: Baseline to 6 months
Functional Oral Intake Scale (FOIS)
Time frame: Baseline to 6 months
Lingual Pressure/movement
Time frame: Baseline to 6 months
Sydney Swallowing Questionnaire (SSQ)
Time frame: Baseline to 6 months
Protocol Adherence Measure
Time frame: Baseline to 6 months
Patient Perception of Swallowing (VAS)
Time frame: Baseline to 6 months
Patient/Caregiver Acceptability/Satisfaction Scale (PA/SS)
Time frame: Baseline to 6 months
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 6 Oct 2026.
- Lab website for Principle Investigator regarding the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study team will report and publish in a peer-reviewed journal (trials journal) the study protocol and proposed analysis, to provide similar information to the national and international scientific community. Information provision and awareness-raising will take place during project inception and intensify as results become available. Study results will be published and displayed on the project webpage following completion of the 6 month follow up of all subjects.
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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.
Giselle Carnaby, PhD, MP principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SwallowFit in people with PARKINSON DISEASE (Disorder), run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 8 inclusion and 14 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 6 Oct 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 United States. 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 Giselle Carnaby, PhD, MPH (210-450-7130, carnaby@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mann Assessment of Swallowing Ability (MASA) (time frame: Baseline to 6 months). The study lists 5 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 6 Oct 2026.