- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00007137
Structure and Function of the Human Tongue
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA
Volunteers must:
- be older than 21 years in age;
- reside in the Metropolitan Washington, D.C. Area;
- have no speech, swallowing, respiratory, or cardiac problems;
- be able to hold breath for at least 20-30 seconds;
- be in good general health;
- not be pregnant or nursing;
- not be on medications that would adversely affect blood pressure, circulation, pulmonary function, speech, or swallowing ability.
Patients must:
- be older than 21 years in age;
- not be pregnant or nursing;
- have tongue weakness, as confirmed in oral motor examination, associated with neurologic, degenerative, musculoskeletal, or other diseases.
EXCLUSION CRITERIA:
Healthy Volunteers:
Any contraindication for MRI, including:
pacemaker or other implanted electronic device
cochlear implants
metal in the eye
embedded shrapnel fragments
cerebral aneurysm clips
medical infusion pumps
orthodontic braces, unremovable metal retainer, dental implants, crowns, long metal bridges, large or multiple amalgam fillings
metal clips or wires in other parts of the body
Medical conditions that present elevated risks or reduced tolerance for an MRI procedure. Examples:
angina
severe and uncontrolled hypertension
severe cardiovascular disorders
dyspnea at rest
severe claudication (less than 1 flight of steps)
paralyzed hemidiaphragm
symptoms of pheochromocytoma or insulinoma
hemoglobinopathies
severe asthma, allergies and postnasal drainage
uncontrolled renal or hepatic disease
severe back pain and inability to tolerate supine positioning
claustrophobia
morbid obesity
pregnancy or lactation
- History of swallowing problems or other conditions that adversely affect cardiac function, deglutitive function, tongue motility and control, hearing, language, and cognition.
- Unsatisfactory performance status, as judged by the examining speech-language pathologist, that indicates poor compliance for the planned tasks (e.g., oral motor deficits, inability to hold breath for at least 20 seconds).
Patients:
- Any contraindication for MRI, same as 5.2.1 (1);
- Medical conditions that present high risks or severely reduced tolerance for an MRI procedure, as determined by or based on consultation with the medically responsible individual (or a designated substitute);
- History of other conditions that have severely impaired cardiac function, hearing, language, and cognition.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 010044
- 01-CC-0044
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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