Clinical trial NCT01971320: Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Official title: Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Oropharyngeal Dysphagia
Deglutition Disorders
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of oropharyngeal dysphagia symptoms
timeFrame: Week 6
Secondary outcomes:
measure: Evaluation of oropharyngeal dysphagia symptoms
timeFrame: Week 6
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: Centre les Herbiers
city: Bordeaux
country: France
facility: UH Bordeaux
city: Limoges
country: France
facility: UH Limoges
city: Paris
country: France
facility: AP-HP Fernand WIDAL
city: Rouen
country: France
facility: UH Rouen
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: UH Rouen
name: Eric VERIN, Professor
role: PRINCIPAL_INVESTIGATOR
References: