Deglutition Disorders, Oropharyngeal Dysphagia
Conditions
Brief 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.
Interventions
DEVICEUrostim I stimulation
Urostim I stimulation will be done during meals for 6 weeks
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of oropharyngeal dysphagia symptoms | Week 6 | Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of oropharyngeal dysphagia symptoms | Week 6 | Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire |
Countries
France
Outcome results
None listed