NCT00001220

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. 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1987

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1987

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2005

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Swallowing DisordersNeuromotor DysfunctionAspirationImaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 3073915BACKGROUND
  • Litvan 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.

    PMID: 9191782BACKGROUND
  • Donner 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.

    PMID: 4421910BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersMotor Neuron Disease

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNeurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

October 1, 1987

Study Completion

November 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-11

Locations