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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01971320
First received: October 23, 2013
Last updated: June 18, 2014
Last verified: June 2014
  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: June 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971320

Locations
France
Centre les Herbiers
Bois-Guillaume, France
UH Bordeaux
Bordeaux, France
UH Limoges
Limoges, France
AP-HP Fernand WIDAL
Paris, France
UH Rouen
Rouen, France
UH Toulouse
Toulouse, France
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: June 18, 2014
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 August 25, 2014