NCT01971320

Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Oropharyngeal Dysphagia
• Deglutition Disorders

Interventions

Type	Name	Description
DEVICE	Urostim I stimulation	Urostim I stimulation will be done during meals for 6 weeks

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-10-29
• Last updated: 2016-08-17

Locations

6 sites across 1 country: France