- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis
Kontakty a umístění
Studijní místa
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
- 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.
Studijní plán
Jak je studie koncipována?
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 010044
- 01-CC-0044
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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