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Clinical Trials/NCT00001936
NCT00001936
Completed
Not Applicable

Feasibility of Neuromuscular Stimulation for Laryngeal Elevation During Swallowing

National Institute of Neurological Disorders and Stroke (NINDS)1 site in 1 country155 target enrollmentSeptember 28, 1999

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deglutition Disorder
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Enrollment
155
Locations
1
Status
Completed
Last Updated
8 years ago

Overview

Brief 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....

Detailed Description

Objectives: 1. To determine if stimulation of the extrinsic laryngeal muscles will elevate the larynx. 2. To determine if augmentation of laryngeal elevation using intra-muscular stimulation will reduce the risk of aspiration in chronic pharyngeal dysphagia. 3. To determine whether stimulation to induce laryngeal elevation assists with opening the upper esophageal sphincter both at rest and during swallowing. 4. To determine whether laryngeal sensation is intact has bearing on the ability of patients with chronic dysphagia to trigger the onset of stimulation in synchrony with their own swallowing. 5. To contrast the effects of surface and intra-muscular stimulation on hyo-laryngeal movement at rest. 6. To contrast the benefits of surface and intra-muscular stimulation on the risk or aspiration/penetration during swallowing. Study Population: Both normal volunteers and patients with severe chronic pharyngeal dysphagia. Design: Hooked wire electrodes and surface electrodes will be used to stimulate extrinsic muscles either alone or in combination both at rest and during swallowing while using videofluoroscopy 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, manometric pressure recordings and cricopharyngeus electromyography will evaluate the effects of muscles stimulation on the upper esophageal sphincter function and blinded ratings of the degree of aspiration and penetration and clearance during swallowing will be conducted by speech-language pathologists to compare the effects of intra-muscular and surface stimulation on swallowing on risk of aspiration and penetration during swallowing.

Registry
clinicaltrials.gov
Start Date
September 28, 1999
End Date
August 18, 2009
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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