Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Oropharyngeal Dysphagia Deglutition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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active stimulation

sensitive electrical stimulation applied during meals with Urostim I for 6 weeks

Urostim I stimulation will be done during meals for 6 weeks

Group Type EXPERIMENTAL

Urostim I stimulation

Intervention Type DEVICE

Urostim I stimulation will be done during meals for 6 weeks

fake stimulation

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

Group Type PLACEBO_COMPARATOR

Urostim I stimulation

Intervention Type DEVICE

Urostim I stimulation will be done during meals for 6 weeks

Interventions

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Urostim I stimulation

Urostim I stimulation will be done during meals for 6 weeks

Intervention Type DEVICE

Eligibility Criteria

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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)