NCT01971320

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

October 23, 2013

Last Update Submit

August 16, 2016

Conditions

Oropharyngeal DysphagiaDeglutition Disorders

Outcome Measures

Primary Outcomes (1)

  • Evaluation of oropharyngeal dysphagia symptoms

    Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)

    Week 6

Secondary Outcomes (1)

  • Evaluation of oropharyngeal dysphagia symptoms

    Week 6

Study Arms (2)

active stimulation

EXPERIMENTAL

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

fake stimulation

PLACEBO COMPARATOR

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

Interventions

Urostim I stimulationDEVICE

Urostim I stimulation will be done during meals for 6 weeks

active stimulationfake stimulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnancy or breast feeding
  • Psychiatric illnes
  • Swallowing disorders before the stroke
  • Contraindication to electrical stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre les Herbiers

Bois-Guillaume, France

Location

UH Bordeaux

Bordeaux, France

Location

UH Limoges

Limoges, France

Location

AP-HP Fernand WIDAL

Paris, France

Location

UH Rouen

Rouen, France

Location

UH Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Eric VERIN, Professor

    UH Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

FR(6)