A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
Condition: Chronic Dysphagia; Multiple Sclerosis; Parkinson Disease
MeSH terms: Deglutition Disorders; Parkinson Disease; Multiple Sclerosis
Intervention: Neurostimulation device for dysphagia; External vibrotactile device
Intervention description: A neurostimulation device that is surgically implanted in the swallowing muscles.; A vibrotactile device that is placed on the neck during swallowing.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Aspiration; Rehabilitation; Swallowing Disorders; Stroke; Parkinson's Disease; Dysphagia; Parkinson Disease; PD

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 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.

      ...
    

Eligibility criteria:

        -  INCLUSION 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.

        EXCLUSION CRITERIA:

          -  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).