Status:
TERMINATED
Videofluoroscopic Swallowing Study (VFSS)
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Cytel Inc.
Regulatory and Clinical Research Institute Inc
Conditions:
Stroke
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse event...
Detailed Description
DDS signals and VFSS will be recorded simultaneously (for the same bolus) using barium contrast agent stimuli prepared in three consistencies: thin, mildly-thick and moderately-thick. Subjects will un...
Eligibility Criteria
Inclusion
- Adult subjects (over 18 years of age)
- Hospitalized subjects or outpatients identified as at risk of oropharyngeal dysphagia (using local practice)
- Patients belong to one of the following groups:
- Stroke patients
- Traumatic brain injury
- Parkinson Disease (PD) stage III or higher by Hoehn and Yahr scale
- Multiple Sclerosis (MS) above age 60
- Alzheimer Disease (AD) or other Dementia
- Other medically complex hospitalized subjects not covered by the exclusion criteria and identified as at risk of dysphagia
- Subject is able to comply with VFSS protocol to diagnose dysphagia
- Subject is able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained / or a consultee has consented on he subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
Exclusion
- Presence of nasogastric / nasojejunal feeding tube at the time of VFSS test
- Currently has a tracheostomy, or has had a tracheostomy in the past year
- Had posterior cervical spine surgery and/or carotid endarterectomy in the last 6 months
- Had significant surgery to the mouth and/or neck, for example resection for oral or pharyngeal cancer, radical neck dissection, anterior cervical spine surgery, orofacial reconstruction, pharyngoplasty, or thyroidectomy. Routine tonsillectomy and/or adenoidectomy are not excluded
- Experienced non-surgical trauma to the neck (e.g., knife wound) resulting in musculoskeletal or nerve injury in the neck.
- Received radiation or chemotherapy to the oropharynx or neck for cancer.
- Allergy to oral radiographic contrast media (specifically barium)
- Distorted oropharyngeal anatomy (e.g. pharyngeal pouch)
- Cognitive impairment that prevents them from being able to comply with study instructions and procedures
- Known to be pregnant at the time of enrollment
- Currently has significant facial hair at the location of sensor adherence and are unwilling/unable to be shaved
- Any patients the local investigator finds that participation would not be in patients' best interest
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2018
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT03387267
Start Date
October 24 2017
End Date
July 23 2018
Last Update
December 19 2025
Active Locations (13)
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1
Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
Medstar Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
4
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611