A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia

Completed · Phase 2

Conditions studied: Chronic Dysphagia, Multiple Sclerosis, Parkinson Disease

In brief

This study will compare an implant with the technique of sensory training to determine which method may improve the ability to swallow and reduce the risk of choking. Many people with a brain injury or neurological disorders experience difficulty in swallowing. Past studies have shown that an electrical pulse applied to muscles or an increase in sensory stimulation to the throat can help. Patients ages 18 to 90 who have had a brain injury or neurological disorder and who have had trouble swallowing for 6 months or longer may be eligible for this study. Patients will undergo a physical examination, pregnancy test, and exam by a throat and speech physician. Fiber-optic endoscopic evaluation of swallowing with sensory testing involves a flexible tube passed through the nose to the back of the throat to allow observation of the voice box. Videofluoroscopy, an X-ray of the head and neck, will be done while patients swallow. Patients experiencing trouble with the upper esophagus may undergo additional procedures, including manometry to measure pressure changes in the back of the throat, and reevaluation through the fiber-optic tube. Patients in this study will have a magnetic resonance imaging (MRI) scan, which uses a strong magnetic field to obtain images of the body. Patients will lie on a table that slides into the enclosed tunnel of the scanner. The scan will take 20 to 25 minutes. Patients will be assigned randomly to one of two groups: the intramuscular group, to have a stimulation device implanted in the neck, and the vibrotactile group, to receive a vibrotactile stimulator. All patients will have 10 training sessions with their devices, plus follow-up. Those patients in the first group will undergo surgery, under general anesthesia, for the implant. Three weeks following the implant procedure, patients will come to NIH to have the stimulator turned on and programmed and to learn how to use the device. Those patients in the second group will have about 2 to 3 weeks of training in using a vibrotactile device, and then they will take it home to use. All patients will return to NIH at 3 months to ensure proper use of the devices, and they will visit for follow-up at 6 months and 12 months for tests and questionnaires. ...

Key facts

Study ID

NCT00376506

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

10

Starts

2006-07-01

Expected to finish

2011-01-01

Last updated by the study team

2012-10-26

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects with Severe or Very Severe Chronic Obstructive Pulmonary Disorder (COPD). Definition of Severe COPD is an FEV(1)/FVC ratio of less than 70% and an FEV(1) of 30 to less than 50% of predicted. The definition of Very severe COPD is an FEV(1)/FVC ratio of less than 70% and an FEV(1) of less than 30% of predicted. Spirometry will be performed according to the standards of the American Thoracic Society using reference values that include a correction for race.
• HIV positive or immune compromised. This is essential because increased risk of immune reactions to the implantation of a foreign device in patients who are immune compromised. Such patients would be at much greater risk of an infection with implantation of a device. Participation would more likely lead to the need an explanation and a second surgery.
• Patients with a pacemaker, deep brain stimulator or other indwelling electrical device.
• History of rapidly progressive neurodegenerative disorders, such as progressive supranuclear palsy, dementia, peripheral neuropathy, multiple systems atrophy or amyotrophic lateral sclerosis.
• Severe oral phase swallowing deficits, due to loss of tongue control, that prevent bolus retention in the oral cavity.
• No aspiration or risk for aspiration in previous assessment or during preliminary studies.
• An esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach.
• Pregnant women will be excluded from participation because the study involves radiation exposure.
• Current psychiatric disorder other than depression. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder.
• Inability to coordinate button press with swallow (as determined during screening).

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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