Deglutition DisorderNCT00001220
Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders
An observational study of Deglutition Disorder and Motor Neuron Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deglutition Disorder, Motor Neuron Disease
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1987to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Food backing up into the mouth or nasal passage.
- Fever or voice changes after swallowing.
- Pain when swallowing.
- Unexplained loss of weight.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Oropharyngeal Dysphagia in Neurologically Impaired Subjects
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:
Read more
- 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.
- 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.
- 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).
- 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.
Read the 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.
- Conditions
- Deglutition Disorder, Motor Neuron Disease
- Keywords
- Swallowing Disorders, Neuromotor Dysfunction, Aspiration, Imaging
- Medical subject headings
- Deglutition Disorders, Motor Neuron Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1987
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisorderStudies 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
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001220
- Sponsor's protocol ID
- 870160
- Other IDs
- 87-CC-0160
- Status last verified
- Nov 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Sonies BC, Parent LJ, Morrish K, Baum BJ. Durational aspects of the oral-pharyngeal phase of swallow in normal adults. Dysphagia. 1988;3(1):1-10. doi: 10.1007/BF02406274. No abstract available.
PubMed 3073915Litvan I, Sastry N, Sonies BC. Characterizing swallowing abnormalities in progressive supranuclear palsy. Neurology. 1997 Jun;48(6):1654-62. doi: 10.1212/wnl.48.6.1654.
PubMed 9191782Donner MW. Swallowing mechanism and neuromuscular disorders. Semin Roentgenol. 1974 Oct;9(4):273-82. doi: 10.1016/0037-198x(74)90045-5. No abstract available.
PubMed 4421910
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Oropharyngeal Dysphagia in Neurologically Impaired Subjects
- ClinicalTrials.gov ID
- NCT00001220
- Acronym / sponsor ID
- 870160
- Conditions
- Deglutition Disorder, Motor Neuron Disease
- Keywords
- Swallowing Disorders, Neuromotor Dysfunction, Aspiration, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Oct 1987
- Study completion
- Nov 2005
- First posted
- 4 Nov 1999 (estimated)
- 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.
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:
- 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.
- 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.
- 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).
- 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3073915Sonies BC, Parent LJ, Morrish K, Baum BJ. Durational aspects of the oral-pharyngeal phase of swallow in normal adults. Dysphagia. 1988;3(1):1-10. doi: 10.1007/BF02406274. No abstract available.
- Background: PubMed 9191782Litvan I, Sastry N, Sonies BC. Characterizing swallowing abnormalities in progressive supranuclear palsy. Neurology. 1997 Jun;48(6):1654-62. doi: 10.1212/wnl.48.6.1654.
- Background: PubMed 4421910Donner MW. Swallowing mechanism and neuromuscular disorders. Semin Roentgenol. 1974 Oct;9(4):273-82. doi: 10.1016/0037-198x(74)90045-5. No abstract available.
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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 Deglutition Disorder and Motor Neuron Disease, run by National Institutes of Health Clinical Center (CC) 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 4 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001220, which also lists 3 linked publications.
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 4 Mar 2008.