Structure and Function of the Human Tongue
|First Received Date ICMJE||December 9, 2000|
|Last Updated Date||March 5, 2008|
|Start Date ICMJE||December 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00007137 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Structure and Function of the Human Tongue|
|Official Title ICMJE||Task-Induced Physiological and Biomechanical Changes of the In Vivo Human Tongue|
This study will use magnetic resonance imaging (MRI) and ultrasound to examine changes in tongue volume and blood circulation during tongue exercises that require the use of different tongue muscle movements and contractions. More information on the structure and function of the human tongue is needed to develop better treatments for people with certain diseases affecting speech and swallowing.
Normal volunteers between 21 and 80 years old who live in the metropolitan Washington, D.C., area may be eligible for this study. Candidates will be screened with a brief medical history and physical examination, including suitability for MRI testing, and a brief examination of tongue, lip and jaw movements.
Participants will undergo ultrasound and MRI studies. During both tests, they will perform tongue exercises, such as holding a soft round object on the tongue or exerting tongue pressure against the back of the throat or roof of the mouth.
During the ultrasound, the subject lies on a flattened dental chair. A small transducer is placed under the chin to take images of the tongue during the exercises. A thin rubber strip with air-filled pressure bulbs is attached to the roof of the mouth (with dental adhesive) to measure tongue pressure.
For the MRI, the subject lies on a table that slides inside a donut's machine containing a magnetic field. MRI coils-special padded sensors that improve image quality-are placed around the head and neck. A pressure cuff placed around the arm measures blood pressure. The subject wears earplugs to muffle loud thumping noises that occur during electrical switching of the magnetic fields. The subject is in constant visual contact with the researchers and MR technologist and may request to stop the study at any time.
Participants may undergo another procedure, called magnetic resonance diffusion tensor imaging, to examine how the fluid (water) in the tongue tissue shifts during tongue maneuvers. This procedure is essentially the same as the first MRI study, but two small round coils are placed in the mouth (one on each side) between the cheeks and the teeth.
|Detailed Description||As an organ unparalleled in anatomical architecture, the tongue has the versatility to effect regional deformations and positional changes with multiple potential degrees of freedom. Despite an abundance of studies on the tongue and its functions, as well as numerous proposed tongue models over the years, much of the anatomical and biomechanical details of the in vivo human tongue remain poorly understood. Physiologically based biomechanical modeling of the tongue in swallowing is the ultimate objective of this protocol. However, before such modeling can be accurately pursued, a substantial database must be established, and several important, unaddressed issues regarding lingual anatomy and biomechanics must be resolved. These issues include: (1) the compressibility of the human tongue and its common, yet untested, reference as a muscular hydrostat; (2) task induced interactions between lingual musculature and vasculature and region-specific vascular demands; (3) changes in lingual fiber orientation, length, and strain distribution as a function of contraction tasks; and (4) effects of normal aging, disease processes, and task training on lingual myoarchitecture as well as the integration between structure and function. Using advanced 3D MRI, Doppler ultrasonography, and other MR imaging techniques (e.g., tagged MRI, diffusion tensor MRI), this protocol proposes to quantitatively address these issues and contribute to a better understanding of the functional biomechanical as well as myoarchitectural intricacies of the in vivo human tongue.|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Hirano M, Kuroiwa Y, Tanaka S, Matsuoka H, Sato K, Yoshida T. Dysphagia following various degrees of surgical resection for oral cancer. Ann Otol Rhinol Laryngol. 1992 Feb;101(2 Pt 1):138-41.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||April 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||21 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00007137|
|Other Study ID Numbers ICMJE||010044, 01-CC-0044|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP