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


Phase 2 Results

Eligibility Criteria

- Inclusive ages of 18 to 90.
- History of cerebral vascular accident (CVA), brain injury or chronic neurological disease such as Parkinson disease or multiple sclerosis or history of chemoradiation for treatment of head and neck cancer resulting in chronic dysphagia.
- Evidence of pharyngeal phase dysphagia that places the patient at risk for aspiration. Risk for aspiration or frank aspiration will be based on the medical history and evidence from a swallowing study. Absence of aspiration is not cause for exclusion if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay include temporary pooling of the material in the vallecula with eventual spill over into the pyriform sinuses. Reduced hyolaryngeal elevation will be identified when the larynx is not protected by epiglottal lowering and remains opens to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance can be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses.
- Other criteria for inclusion for subjects who do not meet the criteria of having aspiration on videofluoroscopy because of the limited number of swallows necessitated by radiation exposure, or who are noncompliant with their NPO status are:
1. Not all of the bolus can enter the esophagus because of reduced opening of the upper esophageal sphincter, as a result there is pooling of the bolus in the pyriform sinuses which will spill over into the airway.
2. Many patients who have had dysphagia for several years, have learned to cough up the bolus from the hypopharynx and spit it out, thus preventing aspiration but are continuing to be unable to ingest food or liquid. This is how they manage their accumulation of saliva by spitting in a cup throughout the day. In this way although they cannot swallow they do not aspirate on examination; rather they clear back up any remaining bolus up into their mouths.
3. Other signs of risk of aspiration are the observation of liquid or food remaining in the pyriform sinuses, a wet gurgling sound during phonation indicating that there is pooling at the vocal folds and coughing when the bolus has already entered the trachea on attempts to swallow.
- Duration of Dysphagia for 6 months or more.
- A score of 2 or greater on the NIH Swallowing Safety Scale.
- Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic exclusion, but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant.
- Prior history of tracheostomy is not a cause for exclusion. Patients currently with a tracheostomy will be excluded.
- Restricted oral intake. Patients should demonstrate a current dependence on alternate means of nutrition and hydration (PEG, PEJ); however, PO intake is not cause for exclusion.
- Adequate cognitive skills as demonstrated by a Mini-Mental State Examination (MMSE) score greater than or equal to 23.
- Stable medical status. To determine if a patient has stable medical status prior to admission, the patient will be asked to provide a letter from their physician stating that the patient is medically stable and may participate in the study.
- 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).