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

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.

Study Overview

• Status: Terminated
• Conditions: Deglutition Disorders; Oropharyngeal Dysphagia
• Intervention / Treatment: Device: Urostim I stimulation

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bois-Guillaume, France
    • Centre les Herbiers
  • Bordeaux, France
    • UH Bordeaux
  • Limoges, France
    • UH Limoges
  • Paris, France
    • AP-HP Fernand WIDAL
  • Rouen, France
    • UH Rouen
  • Toulouse, France
    • UH Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of oropharyngeal dysphagia symptoms	Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of oropharyngeal dysphagia symptoms	Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire	Week 6

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Eric VERIN, Professor, UH Rouen

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2013/002/HP