Deglutition Disorders Clinical Trial
Official title:
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration
pneumonia and denutrition. It could be present in the majority of central neurological
disease (degenerative or vascular disease), which explains that it is the first case of
mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate
that sensitive transcutaneous electrical stimulation could improve swallowing coordination
and reduce aspirations. This technique could be used at home.
The aim of this study is to demonstrate that sensitive electrical stimulation could improve
oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in
seven centers. Sensitive electrical stimulation will be applied either as active
stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz
during 30 minutes, under motor threshold and above sensitive threshold. It will be
administrated via surface electrodes over the hyoid bone. Patients will be separated by
randomisation.
Patients will be evaluated before and after 6 weeks of use. Methods will evaluation
questionnaire, clinical examination and videofluoroscopy. The time of use will also be
collected.
We wish to demonstrate that transcutaneous electrical stimulation is able to improve
oropharyngeal dysphagia in stroke.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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