NCT00007137

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2000

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2000

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2007

Completed
Last Updated

July 2, 2017

Status Verified

April 11, 2007

First QC Date

December 9, 2000

Last Update Submit

June 30, 2017

Conditions

Keywords

3D MRIDiffusion TensorTongueUltrasoundVolumeHealthy VolunteerSwallowingTongue WeaknessTongue Movement Coordination Problem

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations