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Home > "E" Clinical Trials Conditions > Electrical Muscle Stimulation to Aid Swallowing in Dysphagia  Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
For Condition: Deglutition Disorder,Healthy
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: Normal volunteers and patients are being evaluated using neuromuscular stimulation of extrinsic laryngeal muscles to determine if: 1) persons can learn to coordinate the onset of swallowing with stimulation to coordinate neuromuscular stimulation with swallowing, 2) whether concurrent neuromuscular stimulation in dysphagic patients will reduce aspiration during swallowing in persons with delayed onset of laryngeal elevation, reduced extent of laryngeal elevation and/or reduced opening of the upper esophageal sphincter for clearance of the bolus and 3) will increase opening the upper esophageal sphincter for clearance of the bolus from the airway during swallowing.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA FOR NORMAL VOLUNTEERS: We first plan to study normal volunteers in this protocol. INCLUSION CRITERIA FOR PATIENTS: No peripheral laryngeal nerve injury. No laryngeal trauma. Intact cognition and hearing (30 dB HL in speech range); IQ no less than 85. Current dependence on alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN); however, minimal PO is not cause for exclusion. To determine is a patient has stable vital signs prior to admission and a physician has provided approval for participation, the following information will be required depending upon the location of the patient prior to admission. For patients in a nursing home setting, vital signs will be needed 3 days prior to admission and a written form signed by the physician releasing the patient. For patients not in a nursing home a physician's letter of referral written in the past year documenting that the patient is medically stable will be required and a telephone contact with the family or others involved in the patients care that the patient is stable before coming to the NIH. At least 6 months post onset. A Mini-Mental State Examination (MMSE) score greater than or equal to 25. EXCLUSION CRITERIA FOR NORMAL VOLUNTEERS: Subjects will be excluded if they have a history of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will oscultate for cardiac murmurs prior to any study to exclude patients who might be at risk for endocarditis. Pregnancy is a cause for exclusion because the use of Lidocaine during pregnancy is not advisable. Also, pregnancy will exclude women from participation in Study B which 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 will be excluded if they have a history of allergies to lidocaine. The normal volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by a medical history and examination by a physician. 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. None of the subjects included for study will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest either laryngeal paralysis or paresis, joint abnormality or neoplasm. EXCLUSION CRITERIA FOR PATIENTS: 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 24
Total Enrollment: 125
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990178; 99-N-0178
Study Start Date: September 28, 1999
Record last reviewed: September 24, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001936
Other Deglutition Disorder Studies:
1. Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders
2. Study of Tongue Pressures
3. Study of Fetal Swallowing
4. Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
Related Studies:
Other Deglutition Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Electrical Muscle Stimulation to Aid Swallowing in Dysphagia
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