A Comparison of an Implanted Neuroprosthesis With Sensory Training for Improving Airway Protection in Chronic Dysphagia
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Status:
We just finished one year follow-up information on patients in September 2009 and are currently analyzing the results. Hope to have publication available in 6 months (March, 2010).
Purpose:
To determine if an implanted neuroprosthesis improves airway protection for swallowing in chronic pharyngeal dysphagia to a greater degree than sensory training.
Year Started:
2006
Year Finished:
2009
Design:
Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
History of cerebral vascular accident (CVA), brain injury or chronic neurological disease such as Parkinson disease or multiple sclerosis; 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); duration of dysphagia for 6 months or more; score of 2 or greater on the NIH Swallowing Safety Scale; 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); HIV positive or immune compromised; 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; 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; inability to coordinate button press with swallow (as determined during screening).
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.
Primary Outcome:
Swallowing safety for 10 ml of thin liquid and 5 ml of pudding with and without stimulation.
Secondary Outcome:
Quality of Life Patient Questionnaire.
Source of Information:
ClinicalTrials.gov
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This information last updated on: 10/26/2009
Reviewed on: 10/26/2009.
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