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
Study type: Interventional
Phase: Phase 2

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.

      ...
    

Detailed description: 
      Objective: To determine if an implanted neuroprosthesis improves airway protection for
      swallowing in chronic pharyngeal dysphagia to a greater degree than sensory training. The
      implanted neuroprosthesis will provide intramuscular stimulation to as many as 8
      hyo-laryngeal muscles. Stimulation will be coincident with a button press initiation under
      patient control while eating or at regular intervals for saliva swallows during the day
      and/or at night. Sensory training will include vibrotactile stimulation to the neck
      coincident with swallowing under patient control to assist with swallowing while eating or
      for saliva swallows during the day.

      Study population: Persons with chronic (greater than 6 months) dysphagia with risk of
      aspiration secondary to neurological injury, stroke or chronic neurological disease who
      currently require enteric feeding or severe dietary restrictions because of risk of
      aspiration.

      Design: A Phase 2 clinical trial with random assignment between two treatment groups with
      blinded assessment of treatment outcome. Both treatment groups will undergo 2 weeks of device
      training with a speech pathologist. The implant group will undergo training starting 3 weeks
      after implantation. They will receive prescriptive training when the levels of muscles
      stimulation will be established for swallowing. Patients will be trained to press a switch to
      control the stimulation while they are swallowing. The sensory training group will receive
      the same amount of training to provide sensory stimulation coincident with attempting to
      swallow.

      Outcome measures: Blinded assessment of risk of aspiration on videofluoroscopy using the NIH
      Swallowing Safety Scale, and patient administration of the Functional Oral Intake Scale
      (FOIS) for Dysphagia and the Swallowing Quality of Life Outcomes Tool (SWAL_QOL) prior to
      treatment and at 3, 6, 9, and 12 months following treatment. Patient administration of the
      FOIS and SWAL_QOL at 24-months.
    

Intervention name(s): Neurostimulation device for dysphagia; External vibrotactile device
Intervention type(s): Device; Device
Intervention description(s): A neurostimulation device that is surgically implanted in the swallowing muscles.; A vibrotactile device that is placed on the neck during swallowing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Aspiration; Rehabilitation; Swallowing Disorders; Stroke; Parkinson's Disease; Dysphagia; Parkinson Disease; PD