Oropharyngeal Dysphagia | Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Oropharyngeal Dysphagia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Age between 18 and 85 years - No contraindication to electrical stimulation - Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale > 3 or a residue ≥ 50% - Due to an hemispheric stroke - Patients able to understand the videofluroscopy and questionnaires - For women in age of procreation, to have a contraception, a pregnacy test will be done if not - Able to swallow (a nasogastric tube is not a contraindication to participate) Exclusion Criteria: - Pregnancy or breast feeding - Psychiatric illnes - Swallowing disorders before the stroke - Contraindication to electrical stimulation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Urostim I stimulationUrostim I stimulation will be done during meals for 6 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
active stimulationsensitive electrical stimulation applied during meals with Urostim I for 6 weeks Urostim I stimulation will be done during meals for 6 weeks
fake stimulationUrostim 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
Start Date: June 2014
Completed Date: May 2016
Phase: Phase 3
Primary Outcome: Evaluation of oropharyngeal dysphagia symptoms
Secondary Outcome: Evaluation of oropharyngeal dysphagia symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Eric VERIN, Professor
Lead Sponsor: University Hospital, Rouen