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

Study Summary

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 wee

Primary Outcome

Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of \>1 swall

Conditions Studied

Interventions

• DEVICE Neurostimulation device for dysphagia
• DEVICE External vibrotactile device

Study Locations (1)