Electrical Muscle Stimulation to Aid Swallowing in Dysphagia

NCT00001936 | Completed

• 2 other identifiers: 99017899-N-0178
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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....

Conditions

Deglutition Disorder; Healthy

Keywords

Neuromuscular Stimulation; Laryngeal Elevation; Dysphagia; Stroke; Neuroprosthesis; Dysphonia; Aspiration; Motor Control; Videofluoroscopy; Upper Esophageal Sphincter; Healthy Volunteer; Swallowing Disorders

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The normal 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.

You may not qualify if:

• For volunteers undergoing either intra-muscular stimulation or submental surface stiimulation:
• 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 patients 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.
• Subjects will also be excluded if they are taking psychiatric or neuroleptic medications which would interfere with the interpretation of the neurophysiological studies or are taking herbal medications that can affect coagulation.
• Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, current major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.
• Normal volunteers who are pregnant, or have any active medical or psychiatric conditions will not be included for submental surface stimulation, as these may be contraindications.
• For volunteers undergoing intra-muscular stimulation:
• Subjects will be excluded if they have a history of allergies to lidocaine.
• Subjects must be HIV negative. HIV testing for out of town participants may be done prior to traveling to the NIH. This is required because there is no potential benefit for normal volunteers from participation in the study. Because multiple needle insertions are required and the hooked wire electrodes remain in place for 1-2 hours increasing a risk of contamination, persons who are immuno-compromised would be put at undue risk with no opportunity for benefit.
• None of the normal 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.
• Caution will be exercised in patients with suspected or diagnosed heart problems or suspected or diagnosed with epilepsy at the discretion of the physician.
• No peripheral laryngeal nerve injury that results in a lack of glottic closure for swallowing.
• No peripheral nerve injury to the muscles that will be stimulated for hyo-laryngeal elevation.
• No laryngeal trauma that results in a lack of glottic closure for swallowing.
• Intact cognition and hearing (30 dB HL in speech range); IQ no less than 85.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bulow M, Olsson R, Ekberg O. Videomanometric analysis of supraglottic swallow, effortful swallow, and chin tuck in healthy volunteers. Dysphagia. 1999 Spring;14(2):67-72. doi: 10.1007/PL00009589.

  PMID: 10028035 BACKGROUND

• Bergmann K, Warzel H, Eckhardt HU, Hopstock U, Hermann V, Gerhardt HJ. Long-term implantation of a system of electrical stimulation of paralyzed laryngeal muscles in dogs. Laryngoscope. 1988 Apr;98(4):455-9. doi: 10.1288/00005537-198804000-00020.

  PMID: 3258397 BACKGROUND

• Broniatowski M, Sohn J, Kayali H, Bold EL, Miller FR, Jacobs GB, Tucker HM. Artificial reflex arc: a potential solution for chronic aspiration. III: Stimulation of implanted cervical skin as a functional graft triggering glottic closure in the canine. Laryngoscope. 1994 Oct;104(10):1259-63. doi: 10.1288/00005537-199410000-00013.

  PMID: 7934597 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Stroke; Dysphonia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 28, 1999
• Primary Completion: August 18, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-08-18

Locations

US (1)