Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Phase 3

Terminated

• Conditions: Oropharyngeal Dysphagia; Deglutition Disorders
• Interventions: Device: Urostim I stimulation

• Registration Number: NCT01971320
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Study Start: 2014-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fake stimulation	Urostim I 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
active stimulation	Urostim I stimulation	sensitive electrical stimulation applied during meals with Urostim I for 6 weeks Urostim I stimulation will be done during meals for 6 weeks

Primary Outcome Measures

Name	Time	Method
Evaluation of oropharyngeal dysphagia symptoms	Week 6	Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)

Secondary Outcome Measures

Name	Time	Method
Evaluation of oropharyngeal dysphagia symptoms	Week 6	Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire

Trial Locations

Locations (6)

UH Rouen; 🇫🇷 Rouen, France

AP-HP Fernand WIDAL; 🇫🇷 Paris, France

UH Toulouse; 🇫🇷 Toulouse, France

Centre les Herbiers; 🇫🇷 Bois-Guillaume, France

UH Bordeaux; 🇫🇷 Bordeaux, France

UH Limoges; 🇫🇷 Limoges, France