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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active stimulation | Experimental | sensitive electrical stimulation applied during meals with Urostim I for 6 weeks Urostim I stimulation will be done during meals for 6 weeks |
|
| fake stimulation | Placebo Comparator | Urostim I stimulation will be done during meals for 6 weeks Fake sensitive electrical stimulation applied during meals with modified Urostim I who not deliver stimulation for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urostim I stimulation | Device | Urostim I stimulation will be done during meals for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of oropharyngeal dysphagia symptoms | Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of oropharyngeal dysphagia symptoms | Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric VERIN, Professor | UH Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre les Herbiers | Bois-Guillaume | France | ||||
| UH Bordeaux |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Bordeaux |
| France |
| UH Limoges | Limoges | France |
| AP-HP Fernand WIDAL | Paris | France |
| UH Rouen | Rouen | France |
| UH Toulouse | Toulouse | France |
| D010038 | Otorhinolaryngologic Diseases |