- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001167
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing
Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Language Disorders
- Communication Disorders
- Myositis
- Neoplasms
- Polymyositis
- Pharyngeal Neoplasms
- Speech Disorders
- Otorhinolaryngologic Diseases
- Otorhinolaryngologic Neoplasms
Other Study ID Numbers
- 790101
- 79-CC-0101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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