Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia (TENSDEG)

This study is not yet open for participant recruitment.
Verified October 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01971320
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Oropharyngeal Dysphagia
Deglutition Disorders
Device: Urostim I stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Evaluation of oropharyngeal dysphagia symptoms [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)


Secondary Outcome Measures:
  • Evaluation of oropharyngeal dysphagia symptoms [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire


Estimated Enrollment: 118
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Device: Urostim I stimulation
Urostim I stimulation will be done during meals for 6 weeks
Placebo Comparator: 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

Device: Urostim I stimulation
Urostim I stimulation will be done during meals for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971320

Contacts
Contact: Eric VERIN, Professor +3323288 ext 8039 eric.verin@chu-rouen.fr
Contact: Julien BLOT, M +3323288² ext 8265 julien.blot@chu-rouen.fr

Locations
France
Centre les Herbiers Not yet recruiting
Bois-Guillaume, France
Contact: Eric VERIN, Professor    +3323559 ext 0214    eric.verin@ugecam-normandie.fr   
Principal Investigator: Eric VERIN, Professor         
UH Bordeaux Not yet recruiting
Bordeaux, France
Contact: Patrick DEHAIL, Professor    +3355655. ext 6557    patrick.dehail@chu-bordeaux.fr   
Principal Investigator: Patrick DEHAIL, Professor         
UH Limoges Not yet recruiting
Limoges, France
Contact: Jean Y SALLE, Professor    +335 55 05 ext 6518    Jean-Yves.Salle@chu-limoges.fr   
Principal Investigator: Jean Y SALLE, Professor         
AP-HP Fernand WIDAL Not yet recruiting
Paris, France
Contact: Alain YELNICK, Professor    +3314005 ext 42 05    alain.yelnik@lrb.aphp.fr   
Principal Investigator: Alain YELNICK, Professor         
UH Rouen Not yet recruiting
Rouen, France
Contact: Eric VERIN, Professor    +3323288 ext 8039    eric.verin@chu-rouen.fr   
Principal Investigator: Eric VERIN, Professor         
UH Toulouse Not yet recruiting
Toulouse, France
Contact: Xavier DE BOISSEZON, Professor    +3356132 ext 2801    deboissezon.xavier@chu-toulouse.fr   
Principal Investigator: Xavier DE BOISSEZON, Professor         
Sub-Investigator: Virginie WOISARD, Dr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Eric VERIN, Professor UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01971320     History of Changes
Other Study ID Numbers: 2013/002/HP
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014