Electrical Muscle Stimulation to Aid Swallowing in Dysphagia

Completed

Conditions studied: Deglutition Disorder, Healthy

In brief

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....

Key facts

Study ID

NCT00001936

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

155

Starts

1999-09-28

Last updated by the study team

2017-07-02

Who can join

Age: any, up to 90. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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 20.
• Patients who are pregnant, 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 for use of the device. Caution will be exercised in selection of patients with suspected or diagnosed heart problems or suspected or diagnosed with epilepsy at the discretion of the physician.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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