Clinical Study: Swallowing Difficulties

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http://clinicalstudies.info.nih.gov/cgi/wais/bold032001.pl?A_01-CC-0135.html

Protocol Number: 01-CC-0135

Title: Effect of Task on Oral Pressure Dynamics During Swallowing

Number: 01-CC-0135

Summary: This study will examine tongue strength and endurance, how the

tongue applies pressure during swallowing, and how the chin muscles react

during swallowing in healthy volunteers and in patients with dysphagia

(difficulty swallowing). The information from this study may be helpful in

developing better treatments for people with swallowing problems.

Healthy volunteers who have no history of speech, swallowing or breathing

problems and patients who have difficulty swallowing because of a neurologic

disorder, musculoskeletal disease or head and neck cancer that caused tongue

weakness and dysphagia may be eligible for this study. Such medical

conditions may include stroke, Parkinson's disease, multiple sclerosis

corticobasal degeneration, progressive supranuclear palsy, Gaucher's

disease, leukodystrophy, cerebral palsy, myositis, or mouth, throat or neck

cancer. Volunteers who have not participated in a NIH protocol for 1 year

will be screened with a brief medical history and physical examination.

Dysphagic patients not currently enrolled in a NIH protocol will also have a

brief medical history and physical examination. In addition, they will have

a modified barium swallow to determine the nature and degree of their

swallowing difficulty.

Participants will have a 15-minute examination of movements of their tongue,

lips and jaw and will fill out a questionnaire about their swallowing

ability. They will then begin the tongue pressure test. To monitor and

record tongue pressure, a thin rubber strip with air-filled pressure bulbs

will be attached to the roof of the mouth with dental adhesive. The pressure

bulbs are connected to an external pressure-reading device. In addition, a

small plastic pad with adhesive backing will be placed under the chin.

Electrodes (wires) attached to the pad record chin muscle activities.

With the pressure bulbs and chin electrodes in place, the patient will

perform tongue pressure tasks to test tongue strength, how long the patient

can maintain a certain tongue pressure, and how fast tongue pressure drops.

The tasks include saliva swallows, water swallows and cup-drinking.

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): None

Eligibility Criteria:

INCLUSION CRITERIA:

Eligible normal volunteers must:

(1) be at least 21 years of age;

(2) have no speech, swallowing, or respiratory problems;

(3) be in good general health;

(4) not be on medications that would adversely affect swallowing ability.

Eligible dysphagic patients must:

(1) be at least 21 years of age;

(2) have a neurologic disorder (e.g., CVA, PD, PSD, CBD, MS, Gaucher,

leukodystrophy, cerebral palsy), musculoskeletal disease (e.g.,

polymyositis), or head and neck cancer that has caused impairments in tongue

function and swallowing;

(3) present with oral or oropharyngeal dysphagia without aspiration based on

results of the standard modified barium swallow study.

(4) have sufficient auditory comprehension and cognitive skills to follow

test instructions and understand the nature of the study.

EXCLUSION CRITERIA:

(1) History of swallowing problems or other conditions that adversely affect

swallowing function, tongue motility and control, hearing, language, and

cognition.

(2) On medication (e.g., anticholinergics, antidepressants) that adversely

affects swallowing function, tongue movement, comprehension, or cognition.

(3) Oral dryness that interferes with swallowing.

(4) Unsatisfactory performance status, as judged by the examining

speech-language pathologist, that indicates poor compliance for the planned

tasks (e.g., undiagnosed oral motor deficits).

For dysphagic patients:

(1) Aspiration, as identified via the modified barium swallow study.

(2) Pregnancy, as determined via a urine pregnancy test prior to the MBS

test.

Special Instructions: Currently Not Provided

Keywords:

Pressure

Swallowing

Tongue

Recruitment Keywords:

Healthy Volunteer

Dysphagia

Swallowing

Tongue

Conditions:

Deglutition Disorder

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office

Building 61

10 Cloister Court

Bethesda, land 20892-4754

Toll Free: 1-

TTY: (local),1- (toll free)

Fax:

Electronic Mail:prpl@...