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Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

NCT01971320 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Dysphagia
  • Deglutition Disorders

Interventions

DEVICE

Urostim I stimulation

Urostim I stimulation will be done during meals for 6 weeks

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Eric VERIN, Professor · UH Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971320 on ClinicalTrials.gov