Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00001220
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Oropharyngeal Dysphagia in Neurologically Impaired Subjects
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will identify clinical signs and symptoms critical for diagnosing swallowing disorders and will characterize swallowing problems in various patient populations, such as patients with Parkinson's disease, stroke, post-polio syndrome, multiple sclerosis and other conditions that cause swallowing abnormalities.
Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology protocols may be eligible for this study. Participants will undergo the following procedures:
1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.
2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize tongue movements during swallowing.
3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped. The barium is given in three consistencies-thin, medium and thick (pudding-like).
4. Electromyography-A small plastic strip with wires attached is placed under the patient's chin. The patient then swallows 1/2 ounce of barium three times in a row, and the movement of the chin muscles during swallowing is displayed. Patients may also be asked to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the head untilted.
Depending on the test results, patients may be asked to return for follow-up study and monitoring.
Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology protocols may be eligible for this study. Participants will undergo the following procedures:
1. Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.
2. Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize tongue movements during swallowing.
3. Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped. The barium is given in three consistencies-thin, medium and thick (pudding-like).
4. Electromyography-A small plastic strip with wires attached is placed under the patient's chin. The patient then swallows 1/2 ounce of barium three times in a row, and the movement of the chin muscles during swallowing is displayed. Patients may also be asked to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the head untilted.
Depending on the test results, patients may be asked to return for follow-up study and monitoring.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 87-CC-0160 | None | None | View |