Effect of Surface Electrical Stimulation on Movement of the Larynx

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00104000
First received: February 17, 2005
Last updated: March 3, 2008
Last verified: January 2006
  Purpose

This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. It is important that the larynx moves up and forward while swallowing so that food does not go into the airway. A device called VitalStim® (Registered Trademark), which provides electrical stimulation to the skin on the neck and under the chin, is widely used to treat people who have problems swallowing. This study will determine if VitalStim can move the voice box or the vocal folds in the larynx. This information is important for patients who have long-term problems raising or closing their larynxes when they swallow.

Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is passed through the nose to the back of the throat. The scope allows observation of the larynx while the subject speaks, sings, whistles and makes prolonged vowel sounds.

Participants are familiarized with the VitalStim device before beginning the experimental procedures. The device consists of two sets of electrodes and a stimulation unit. The electrodes are placed on the neck and under the chin. Stimulation causes different sensations, according to the intensity level. They include "tingling/crawling," "vibrating" "warm/burning," and "grabbing." Subjects then undergo the following procedures:

  • Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a decongestant and the nasoendoscope is passed through one nostril to the back of the throat. Electrodes are placed on the throat area and under the chin. Stimulation is delivered 10 times at various places on the neck and under the chin while the subject sits quietly. This test shows if the vocal folds in the voice box move with surface electrical stimulation.
  • Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray study of the head and neck during swallowing and at rest to determine how stimulation affects the level of the voice box in the neck. Electrodes are placed under the chin and on the throat. The subject swallows 5 milliliters of barium, a contrast material that can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time during each swallow of the barium and another 10 times while the subject is remaining still without swallowing.

Condition
Healthy

Study Type: Observational
Official Title: The Effect of Surface Electrical Stimulation on Hyo-Laryngeal Movement in Healthy Individuals at Rest and During Swallow

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 47
Study Start Date: February 2005
Estimated Study Completion Date: January 2006
Detailed Description:

Objectives:

The purpose of the current study is to determine whether:

  1. Surface electrical stimulation at rest using various electrode placements produces different hyo-laryngeal movements of in healthy adult humans.
  2. One surface electrical stimulation array (placement 3b) reduces hyo-larynegeal movement in healthy humans during swallowing.

Study Population: healthy adults

Design: This study will employ a repeated measures design. Surface electrodes will be used to stimulate submental and laryngeal muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy and nasolaryngoscopy to record hyo-laryngeal movement.

Outcome Measures: Kinematic analyses of hyo-laryngeal movements using image processing and marking from video-recordings will quantify movement with stimulation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

  • History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to exclude volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study.
  • Pregnancy will exclude women from participation because the study involves radiation exposure.
  • None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm.
  • Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104000

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00104000     History of Changes
Other Study ID Numbers: 050099, 05-N-0099
Study First Received: February 17, 2005
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Neuromuscular
Elevation
Current
Videofluoroscopy
Nasoendoscopy
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on July 26, 2014