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

University Hospital, Rouen

Status and phase: Terminated; Phase 3

Conditions: Oropharyngeal Dysphagia; Deglutition Disorders

Treatments: Device: Urostim I stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01971320

2013/002/HP

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

active stimulation

Experimental group

Description:

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

Treatment:

Device: Urostim I stimulation

fake stimulation

Placebo Comparator group

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

Treatment:

Device: Urostim I stimulation