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| Sponsored by: |
National Institutes of Health Clinical Center (CC) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001167 |
Purpose
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.
| Condition |
|---|
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Otorhinolaryngologic Disease Otorhinolaryngologic Neoplasm Pharyngeal Neoplasm Polymyositis Speech Disorder |
| Study Type: | Observational |
| Official Title: | Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx |
| Estimated Enrollment: | 570 |
| Study Start Date: | August 1979 |
| Estimated Study Completion Date: | November 2004 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
| Study ID Numbers: | 790101, 79-CC-0101 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001167 |
| Health Authority: | United States: Federal Government |
|
Dysphagia Dysarthria Tongue Motion Xerostomia Swallowing |
Speech Polymyositis Speech Disorders Oral-Facial Paralysis Ultrasound |
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Speech Disorders Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Facies Language Disorders Pharyngeal Neoplasms Pharyngeal Diseases Xerostomia Facial Paralysis Deglutition Disorders Paralysis Myositis |
Signs and Symptoms Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Dysarthria Head and Neck Neoplasms Polymyositis Idiopathic myopathy Neurologic Manifestations Stomatognathic Diseases Neurobehavioral Manifestations Communication Disorders |
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Neoplasms Neoplasms by Site Nervous System Diseases |
