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

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ClinicalTrials.gov Identifier: NCT01971320
Recruitment Status : Terminated (lack of recruitment)
First Posted : October 29, 2013
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

October 23, 2013
October 29, 2013
August 17, 2016
June 2014
May 2016   (Final data collection date for primary outcome measure)
Evaluation of oropharyngeal dysphagia symptoms [ Time Frame: Week 6 ]
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)
Same as current
Complete list of historical versions of study NCT01971320 on ClinicalTrials.gov Archive Site
Evaluation of oropharyngeal dysphagia symptoms [ Time Frame: Week 6 ]
Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire
Same as current
Not Provided
Not Provided
 
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Oropharyngeal Dysphagia
  • Deglutition Disorders
Device: Urostim I stimulation
Urostim I stimulation will be done during meals for 6 weeks
  • 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

    Intervention: Device: Urostim I stimulation
  • 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

    Intervention: Device: Urostim I stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
118
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01971320
2013/002/HP
No
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Eric VERIN, Professor UH Rouen
University Hospital, Rouen
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP