Structure and Function of the Human Tongue
Task-Induced Physiological and Biomechanical Changes of the In Vivo Human Tongue
2 other identifiers
observational
165
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2000
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2000
CompletedFirst Submitted
Initial submission to the registry
December 9, 2000
CompletedFirst Posted
Study publicly available on registry
December 11, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2007
CompletedJuly 2, 2017
April 11, 2007
December 9, 2000
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (1)
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. doi: 10.1177/000348949210100206.
PMID: 1739258BACKGROUND
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 9, 2000
First Posted
December 11, 2000
Study Start
December 5, 2000
Study Completion
April 11, 2007
Last Updated
July 2, 2017
Record last verified: 2007-04-11