NIH Clinical Research Studies

Protocol Number: 99-N-0178

Active Accrual, Protocols Recruiting New Patients

Title:
Feasibility of Neuromuscular Stimulation for Laryngeal Elevation During Swallowing
Number:
99-N-0178
Summary:
The purpose of this study is to determine the feasibility of using extrinsic laryngeal muscle stimulation to elevate the larynx in a manner similar to that which occurs during normal swallowing. This research will also determine whether laryngeal elevation will open the upper esophageal sphincter to assist with entry of the bolus into the esophagus. This protocol includes studies in normal volunteers and patients with swallowing disorders. The outcome of this study will be relevant to future use of neuromuscular stimulation for laryngeal elevation in patients with pharyngeal dysphagia.
Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA FOR NORMAL VOLUNTEERS:

We first plan to study normal volunteers in this protocol.

INCLUSION CRITERIA FOR PATIENTS:

No peripheral laryngeal nerve injury.

No laryngeal trauma.

Intact cognition and hearing (30 dB HL in speech range); IQ no less than 85.

Current dependence on alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN); however, minimal PO is not cause for exclusion.

To determine is a patient has stable vital signs prior to admission and a physician has provided approval for participation, the following information will be required depending upon the location of the patient prior to admission. For patients in a nursing home setting, vital signs will be needed 3 days prior to admission and a written form signed by the physician releasing the patient. For patients not in a nursing home a physician's letter of referral written in the past year documenting that the patient is medically stable will be required and a telephone contact with the family or others involved in the patients care that the patient is stable before coming to the NIH.

At least 6 months post onset.

A Mini-Mental State Examination (MMSE) score greater than or equal to 25.

EXCLUSION CRITERIA FOR NORMAL VOLUNTEERS:

Subjects will be excluded if they have a history of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG.

A physician will oscultate for cardiac murmurs prior to any study to exclude patients who might be at risk for endocarditis.

Pregnancy is a cause for exclusion because the use of Lidocaine during pregnancy is not advisable. Also, pregnancy will exclude women from participation in Study B which involves radiation exposure.

Subjects will also be excluded if they are taking psychiatric or neuroleptic medications which would interfere with the interpretation of the neurophysiological studies or are taking herbal medications that can affect coagulation.

Subjects will be excluded if they have a history of allergies to lidocaine.

The normal volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by a medical history and examination by a physician.

Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study.

Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, current major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.

None of the subjects included for study will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest either laryngeal paralysis or paresis, joint abnormality or neoplasm.

EXCLUSION CRITERIA FOR PATIENTS:

History of progressive neurodigestive disease, amyotrophic lateral sclerosis, etc

History of swallowing difficulties prior to most recent or previous CVA's

Dementia, obtundation, somnolence, and agitation

More than 90 years of age

A tracheostomy that fixes the laryngeal position interfering with the possibility of elevation

Moderate to severe oral phase swallowing dysfunction

Pharyngeal structural abnormalities on videofluoroscopy including mass and diverticulum

Esophageal motility not within normal range of function appropriate for the patient's age

Patient on a regular diet without difficulties

A MMSE score less than or equal to 24

Special Instructions: Currently Not Provided
Keywords:
Neuromuscular Stimulation
Laryngeal Elevation
Dysphagia
Stroke
Neuroprosthesis
Dysphonia
Aspiration
Motor Control
Videofluoroscopy
Upper Esophageal Sphincter
Recruitment Keywords:
Healthy Volunteer
Swallowing Disorders
Dysphagia
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, 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:
Videomanometric analysis of supraglottic swallow, effortful swallow, and chin tuck in healthy volunteers

Long-term implantation of a system of electrical stimulation of paralyzed laryngeal muscles in dogs

Artificial reflex arc: a potential solution for chronic aspiration III: Stimulation of implanted cervical skin as a functional graft triggering glottic closure in the canine

Active Accrual, Protocols Recruiting New Patients

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