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Cortical Neuromodulation in Post Stroke Dysphagia

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01345890
First received: February 17, 2009
Last updated: April 29, 2011
Last verified: April 2011
History of Changes
  Purpose

The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.


Condition Intervention
Dysphagia
 Procedure: electrical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Neuromodulation in Post Stroke Dysphagia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • videofluoroscopy [ Time Frame: before and after (once a day for 5 consecutive days) ] [ Designated as safety issue: No ]
    measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing


Enrollment: 20
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: electrical stimulation
stroke patients
 Procedure: electrical stimulation
sub motor threshold stimulation of mylohyoid muscles

Detailed Description:

Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post stroke dysphagia

Exclusion Criteria:

  • contraindication to magnetic stimulation, unability to accept the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345890

Locations
France
Rouen Universty Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Eric VERIN, MD-PhD Rouen University
  More Information

No publications provided

Responsible Party: E VERIN, Rouen University Hopsital
ClinicalTrials.gov Identifier: NCT01345890     History of Changes
Other Study ID Numbers: 2004/008/HP
Study First Received: February 17, 2009
Last Updated: April 29, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
swallowing
stroke
aspiration
 human
electrical stimulation
post stroke dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013