A randomized trial of NMES vs. traditional dysphagia therapy after stroke

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DESCRIPTION (provided by applicant): Stroke is the third most common cause of death and leading cause of long-term disability in the USA. A common complication of stroke is difficulty swallowing (dysphagia). Dysphagia is often associated with aspiration leading to pneumonia, prolonged hospital stay and poorer recovery from stroke. Recent studies reveal that dysphagia following stroke is a widely prevalent problem, however the associated treatments for dysphagia are applied haphazardly, with variable degrees of a range of interventions applied. Further it is not clear whether those techniques applied are effective (or even risky), because few studies have adequately evaluated these techniques. Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, with over 7000 speech language pathologists in the USA conducting this treatment with stroke patients, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care - behavioral swallowing therapy arm. Following randomization, all subjects will undergo a video-x-ray (modified barium swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide objective data about the nature and degree of dysphagia. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. All subjects will be asked to complete a diary card to record any change in status or diet between the post treatment and 3 month follow up reviews. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. Clinically meaningful improvement for this study is defined a priori, as an increase of 10 or more points on the Mann Assessment of Swallowing (MASA) and improvement of =2 scale points on the Functional Oral Intake scale (FOIS), without significant weight loss or dysphagia-related complications. Secondary outcomes include the improvement in the physiology of swallowing (biomechanical analysis), recovery of a pre-stroke diet, and the occurrence of dysphagia-related medical complications. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community. PUBLIC HEALTH RELEVANCE: This randomized clinical trial will determine the benefit of NMES for swallowing. These results will be invaluable in developing effective management strategies and directing appropriate health care resources for the treatment of dysphagia following stroke.