Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
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|ClinicalTrials.gov Identifier: NCT00001936|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
|Condition or disease|
|Deglutition Disorder Healthy|
- To determine if stimulation of the extrinsic laryngeal muscles will elevate the larynx.
- To determine if augmentation of laryngeal elevation using intra-muscular stimulation will reduce the risk of aspiration in chronic pharyngeal dysphagia.
- To determine whether stimulation to induce laryngeal elevation assists with opening the upper esophageal sphincter both at rest and during swallowing.
- 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.
- To contrast the effects of surface and intra-muscular stimulation on hyo-laryngeal movement at rest.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||155 participants|
|Official Title:||Feasibility of Neuromuscular Stimulation for Laryngeal Elevation During Swallowing|
|Study Start Date :||September 28, 1999|
|Primary Completion Date :||August 18, 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001936
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|