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

Primary Purpose

Oropharyngeal Dysphagia, Deglutition Disorders

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Urostim I stimulation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Dysphagia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre les Herbiers
  • UH Bordeaux
  • UH Limoges
  • AP-HP Fernand WIDAL
  • UH Rouen
  • UH Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active stimulation

fake stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluation of oropharyngeal dysphagia symptoms
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)

Secondary Outcome Measures

Evaluation of oropharyngeal dysphagia symptoms
Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire

Full Information

First Posted
October 23, 2013
Last Updated
August 16, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01971320
Brief Title
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Acronym
TENSDEG
Official Title
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia, Deglutition Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active stimulation
Arm Type
Experimental
Arm Description
sensitive electrical stimulation applied during meals with Urostim I for 6 weeks Urostim I stimulation will be done during meals for 6 weeks
Arm Title
fake stimulation
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Urostim I stimulation
Intervention Description
Urostim I stimulation will be done during meals for 6 weeks
Primary Outcome Measure Information:
Title
Evaluation of oropharyngeal dysphagia symptoms
Description
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Evaluation of oropharyngeal dysphagia symptoms
Description
Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERIN, Professor
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre les Herbiers
City
Bois-Guillaume
Country
France
Facility Name
UH Bordeaux
City
Bordeaux
Country
France
Facility Name
UH Limoges
City
Limoges
Country
France
Facility Name
AP-HP Fernand WIDAL
City
Paris
Country
France
Facility Name
UH Rouen
City
Rouen
Country
France
Facility Name
UH Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

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