Healthy Clinical Trial
Official title:
Feasibility of Neuromuscular Stimulation for Laryngeal Elevation During Swallowing
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....
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.
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