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Structure and Function of the Human Tongue

30 de junio de 2017 actualizado por: National Institutes of Health Clinical Center (CC)

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción

165

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

5 de diciembre de 2000

Finalización del estudio

11 de abril de 2007

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2000

Primero enviado que cumplió con los criterios de control de calidad

9 de diciembre de 2000

Publicado por primera vez (Estimar)

11 de diciembre de 2000

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2017

Última verificación

11 de abril de 2007

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 010044
  • 01-CC-0044

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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