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Ultrasound Evaluation of Tongue Movements in Speech and Swallowing

Primary Purpose

Otorhinolaryngologic Disease, Otorhinolaryngologic Neoplasm, Pharyngeal Neoplasm

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Otorhinolaryngologic Disease focused on measuring Dysphagia, Dysarthria, Tongue Motion, Xerostomia, Swallowing, Speech, Polymyositis, Speech Disorders, Oral-Facial Paralysis, Ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Normal volunteers: Normal volunteers ages 21 to 85 may be asked to participate in a study of speech and swallowing utilizing a traditional clinical examination of oral-motor performance. If the subjects are without deficits in dental occlusion, speech articulation, tongue and lip strength, tongue and lip mobility, palatal function and oral sensation they will be asked to participate in an ultrasonic evaluation of tongue/hyoid interaction during swallowing and speech. Children will be included if they are referred with a medical condition that affects the oral pharyngeal phase of swallowing, voice production or laryngeal function and the investigator needs to evaluate functional performance and safety for oral feeding. Neurological Group: Subjects aged 6 to 85 with diagnosed developmental, neuromotor, systemic, genetic, neurologic, structural and post surgical dysfunction who have deficits in speech (dysarthria) and/or swallow (dysphagia) may be asked to participate in this study of ultrasonic imaging. Aging patients with and without dementia may also be studied. Patients with Post Polio Syndrome, Polymyositis, Dermatomyositis, Toricollis, Cerebellar Degeneration, Parkinson's disease, Progressive Supranuclear Palsy, ALS, Cystinosis, are among the conditions of interest. Subjects with complaints of oral dryness, and patients who have undergone mandibular and oral surgery may also be studied during swallowing. Oropharyngeal/Laryngeal Tumors: Patients will be seen who are enrolled in NCI and NIDCD protocols for head and neck tumors. EXCLUSION CRITERIA Normal Subjects: Hearing impairment reported (above 40 db, bilaterally) Dentures Oral Prosthesis Palatal surgery or other restorative dental surgery Radial neck dissection, glossectomy Tumor or masses in neck or tongue Cerebral vascular attack Stuttering Non-English speaker Childhood articulation impairment

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001167
Brief Title
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing
Official Title
Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx
Study Type
Observational

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
August 1979 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

Brief Summary
This study will assess the use of ultrasound-a test that uses sound waves to produce images-as a diagnostic tool for evaluating speech and swallowing. The following categories of individuals may be eligible for this study: 1) healthy volunteers between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old with developmental neurological deficits in speech or swallowing, and 3) patients with tumors of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center. Participants will undergo a 30-minute speech and oral motion evaluation, in which they imitate sounds, words and oral movements while a speech pathologist evaluates their lip, tongue and palate movements. They may also be asked to drink a small amount of water for examination of swallowing function. For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the participant's chin. While the transducer is in place, the subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat pudding. The ultrasound images are recorded on tape for later analysis.
Detailed Description
Studies conducted using ultrasound imaging at the NIH, Departments of Rehabilitation Medicine and Diagnostic Radiology, have demonstrated that ultrasound imaging can be used reliably to study speech and swallowing impairments in a variety of conditions and diseases. Since ultrasound is non-invasive with no reported bioeffects, it can be used repeatedly to follow the progression of a disease. Ultrasound imaging of the oral cavity during speech and swallowing allows easy visualization of the tongue/hyoid bone motion and transport of the bolus during swallowing and tongue surface configuration during speech. Images can be obtained in several planes for viewing muscular coordination and timing and specific measures can be obtained from digitized video images. Thus it has widespread clinical research implications for patients with disorders affecting the oral peripheral muscles, salivary gland flow and the central nervous system control of speech and swallowing. While ultrasound technology has been used extensively in Europe to evaluate tumors of the head and neck, its use in this country has been marginal. We plan to compare ultrasound evaluation of tumor staging, tumor volume, and tumor recurrence in patients with tumors of the larynx, oral cavity and hypopharynx. Currently, this is accomplished by CT or MRI scanning procedures. We plan to compare CT/MRI results with ultrasound to determine if this non-invasive technique can be utilized reliably for diagnosis and tracking of oropharyngeal tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otorhinolaryngologic Disease, Otorhinolaryngologic Neoplasm, Pharyngeal Neoplasm, Polymyositis, Speech Disorder
Keywords
Dysphagia, Dysarthria, Tongue Motion, Xerostomia, Swallowing, Speech, Polymyositis, Speech Disorders, Oral-Facial Paralysis, Ultrasound

7. Study Design

Enrollment
570 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Normal volunteers: Normal volunteers ages 21 to 85 may be asked to participate in a study of speech and swallowing utilizing a traditional clinical examination of oral-motor performance. If the subjects are without deficits in dental occlusion, speech articulation, tongue and lip strength, tongue and lip mobility, palatal function and oral sensation they will be asked to participate in an ultrasonic evaluation of tongue/hyoid interaction during swallowing and speech. Children will be included if they are referred with a medical condition that affects the oral pharyngeal phase of swallowing, voice production or laryngeal function and the investigator needs to evaluate functional performance and safety for oral feeding. Neurological Group: Subjects aged 6 to 85 with diagnosed developmental, neuromotor, systemic, genetic, neurologic, structural and post surgical dysfunction who have deficits in speech (dysarthria) and/or swallow (dysphagia) may be asked to participate in this study of ultrasonic imaging. Aging patients with and without dementia may also be studied. Patients with Post Polio Syndrome, Polymyositis, Dermatomyositis, Toricollis, Cerebellar Degeneration, Parkinson's disease, Progressive Supranuclear Palsy, ALS, Cystinosis, are among the conditions of interest. Subjects with complaints of oral dryness, and patients who have undergone mandibular and oral surgery may also be studied during swallowing. Oropharyngeal/Laryngeal Tumors: Patients will be seen who are enrolled in NCI and NIDCD protocols for head and neck tumors. EXCLUSION CRITERIA Normal Subjects: Hearing impairment reported (above 40 db, bilaterally) Dentures Oral Prosthesis Palatal surgery or other restorative dental surgery Radial neck dissection, glossectomy Tumor or masses in neck or tongue Cerebral vascular attack Stuttering Non-English speaker Childhood articulation impairment
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2011159
Citation
Sonies BC, Dalakas MC. Dysphagia in patients with the post-polio syndrome. N Engl J Med. 1991 Apr 25;324(17):1162-7. doi: 10.1056/NEJM199104253241703.
Results Reference
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PubMed Identifier
2381441
Citation
Sonies BC, Ekman EF, Andersson HC, Adamson MD, Kaler SG, Markello TC, Gahl WA. Swallowing dysfunction in nephropathic cystinosis. N Engl J Med. 1990 Aug 30;323(9):565-70. doi: 10.1056/NEJM199008303230903.
Results Reference
background
PubMed Identifier
6398320
Citation
Shawker TH, Sonies B, Hall TE, Baum BF. Ultrasound analysis of tongue, hyoid, and larynx activity during swallowing. Invest Radiol. 1984 Mar-Apr;19(2):82-6. doi: 10.1097/00004424-198403000-00003.
Results Reference
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Ultrasound Evaluation of Tongue Movements in Speech and Swallowing

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