Protocol Number: 01-CC-0044

Title:

Task-Induced Physiological and Biomechanical Changes of the In Vivo Human Tongue

Number:

01-CC-0044

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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA

Volunteers must:

(1) be older than 21 years in age;

(2) reside in the Metropolitan Washington, D.C. Area;

(3) have no speech, swallowing, respiratory, or cardiac problems;

(4) be able to hold breath for at least 20-30 seconds;

(5) be in good general health;

(6) not be pregnant or nursing;

(7) not be on medications that would adversely affect blood pressure, circulation, pulmonary function, speech, or swallowing ability.

Patients must:

(1) be older than 21 years in age;

(2) not be pregnant or nursing;

(3) have tongue weakness, as confirmed in oral motor examination, associated with neurologic, degenerative, musculoskeletal, or other diseases.

EXCLUSION CRITERIA:

Healthy Volunteers:

(1) 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

(2) 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

(3) History of swallowing problems or other conditions that adversely affect cardiac function, deglutitive function, tongue motility and control, hearing, language, and cognition.

(4) 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:

(1) Any contraindication for MRI, same as 5.2.1 (1);

(2) 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);

(3) History of other conditions that have severely impaired cardiac function, hearing, language, and cognition.

Special Instructions: Currently Not Provided

Keywords:

3D MRI

Diffusion Tensor

Tongue

Ultrasound

Volume

Recruitment Keywords:

Healthy Volunteer

Tongue

Swallowing

Conditions:

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Quantitative assessment of pharyngeal bolus driving forces

Analysis of pressure generation and bolus transit during pharyngeal swallowing

Dysphagia following various degrees of surgical resection for oral cancer

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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