Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001167
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 34-inch transducer device for transmitting and receiving sound waves is placed under the participants 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
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 34-inch transducer device for transmitting and receiving sound waves is placed under the participants 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 tonguehyoid 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 CTMRI results with ultrasound to determine if this non-invasive technique can be utilized reliably for diagnosis and tracking of oropharyngeal tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 79-CC-0101 | None | None | None |