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Cortical Neuromodulation in Post Stroke Dysphagia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345890
First Posted: May 2, 2011
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Neuromodulation in Post Stroke Dysphagia

Resource links provided by NLM:


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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post stroke dysphagia

Exclusion Criteria:

  • contraindication to magnetic stimulation, unability to accept the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01345890     History of Changes
Other Study ID Numbers: 2004/008/HP
First Submitted: February 17, 2009
First Posted: May 2, 2011
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

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