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

Completed

Phase 2 Results

Trial Description

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.
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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.

Conditions

Interventions

  • Neurostimulation System for Dysphagia Device
    Intervention Desc: A comparison of the use of an implanted neurostimulation device with an external vibrotactile device for retraining swallowing
    ARM 1: Kind: Experimental
    Label: External Device
    Description: Patient controlled retraining device with automatic cycling
    ARM 2: Kind: Experimental
    Label: Implanted Device
    Description: Patient controlled retraining device with automatic cycling
  • Neurostimulation device for dysphagia Device
    Intervention Desc: A neurostimulation device that is surgically implanted in the swallowing muscles.
    ARM 1: Kind: Experimental
    Label: Implanted Device
    Description: Implanted intramuscular neurostimulator device
  • External vibrotactile device Device
    Intervention Desc: A vibrotactile device that is placed on the neck during swallowing.
    ARM 1: Kind: Experimental
    Label: External Device
    Description: External vibrotactile device

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Subjects will have 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. 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, 12, and 24 months following treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Swallowing safety for 10 ml of thin liquid and 5 ml of pudding with and without stimulation.
Secondary Quality of Life Patient Questionnaire.
Primary Swallowing safety for 10 ml of thin liquid and 5 ml of pudding with and without stimulation Every 3 months for first year and at 2 years post training initiation Yes
Secondary Quality of Life Patient Questionnaire Every 3 months for first year and at 2 years post training initiation Yes
Primary Swallowing Safety for 10 ml of Thin Liquid Baseline and 12-months post-treatment Yes
Primary Swallowing Safety for 5 ml of Pudding Baseline and 12-months post-treatment Yes
Secondary Penetration-Aspiration Scale for 10 ml Thin Liquid Baseline and 12-months post-treatment Yes
Secondary Penetration-Aspiration Scale for 5 ml Pudding Baseline and 12-months post-treatment Yes
Secondary Functional Oral Intake Scale (FOIS) for Dysphagia Baseline and 12-months post-treatment No

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