Completed

Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx

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What is being collected

Data Collection

Who is being recruted

Articulation Disorders+31

+ Behavior

+ Communication

See all eligibility criteria
How is the trial designed

Observational
Study Start: August 1979
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1979

Actual date on which the first participant was enrolled.

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.

NCT00001167
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

570 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Articulation DisordersBehaviorCommunicationCommunication DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesHead and Neck NeoplasmsLanguage DisordersStomatognathic DiseasesMouth DiseasesMuscular DiseasesMusculoskeletal DiseasesMyositisNeoplasmsNeoplasms by SiteNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPharyngeal DiseasesSalivary Gland DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVerbal BehaviorNeurobehavioral ManifestationsDeglutition DisordersDysarthriaOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal NeoplasmsSpeechSpeech DisordersXerostomiaPolymyositis

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Warren G. Magnuson Clinical Center (CC)

Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps
CompletedOne Study Center