Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Deglutition Disorders Clinical Trial

— TENSDEG  

Official title:

Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01971320
• Other study ID #: 2013/002/HP
• Status: Terminated
• Phase: Phase 3
• First received: October 23, 2013
• Last updated: August 16, 2016
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of oropharyngeal dysphagia symptoms	Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)	Week 6	No
Secondary	Evaluation of oropharyngeal dysphagia symptoms	Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire	Week 6	No