Completed

Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Oropharyngeal Dysphagia in Neurologically Impaired Subjects

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What is being collected

Data Collection

Who is being recruted

Deglutition Disorders+7

+ Digestive System Diseases

+ Esophageal Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: October 1987
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1987

Actual date on which the first participant was enrolled.

Patients with neurological or neuromuscular conditions may be silent aspirators or at risk for laryngeal penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk for aspiration pneumonia and its serious effects. By providing identification of the components of the abnormal swallow, and comparing swallowing across tasks, we may avoid aspiration and can instruct patients on preventative or compensatory swallowing techniques. We will study the oral, pharyngeal and upper esophageal phases of swallow using both ultrasonic imaging and videofluoroscopy in patients with neurologic, genetic, systemic, and neuromuscular conditions. Most of the previous studies of swallowing have utilized only one diagnostic imaging technique and have thus provided an incomplete swallowing assessment as each procedure has unique, but limited capabilities for visualizing the anatomy and physiology of the swallow. We also plan to compare discrete and continuous swallowing in these populations. While the motor physiology for discrete swallowing (i.e., single swallow) has been well studied, little is known about the details of oral, laryngeal, and pharyngeal coordination during sequential swallowing as a part of continuous drinking--a common event in everyday eating. A portion of the protocol will study the effects of fast-paced movement sequencing on the coordination of the tongue, velum, larynx, and pharynx during continuous drinking. Videofluoroscopy and ultrasound may be paired or used individually to collect data from normal subjects and patients with known dysphagia while they perform sequential and discrete swallowing tasks. A number of timing and displacement measurements of the structures activated during these tasks will be made from the digitized video images of each swallow, and analyses will be carried out subsequently across tasks and subjects.

Official TitleComparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Oropharyngeal Dysphagia in Neurologically Impaired Subjects
NCT00001220
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNervous System DiseasesNeuromuscular DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesMotor Neuron DiseaseNeurodegenerative Diseases

Criteria

INCLUSION CRITERIA: Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any other NIH institute protocol can be included for study as well as patients who are admitted specifically for this protocol. Those patients at risk for oropharyngeal dysfunction will be screened initially by completing a self-assessment swallowing questionnaire, and by an interview with staff and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia and oral motor impairment on the screening assessment will be considered for the protocol: Difficulty swallowing food or pills. Changed swallowing ability. Coughing or choking when eating. Shortness of breath during swallowing. Food backing up into the mouth or nasal passage. Fever or voice changes after swallowing. Pain when swallowing. Unexplained loss of weight. EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Patients who are non-ambulatory will be excluded if they can not be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment. Infants and children under age 3 will be excluded due to radiation risk on the developing visual system.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center (CC)

Bethesda, United StatesOpen National Institutes of Health Clinical Center (CC) in Google Maps
CompletedOne Study Center