Back to resultsCortical Neuromodulation in Post Stroke Dysphagia
Primary Purpose
Dysphagia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrical stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphagia focused on measuring swallowing, stroke, aspiration, human, electrical stimulation, post stroke dysphagia
Eligibility Criteria
Inclusion Criteria:
- post stroke dysphagia
Exclusion Criteria:
- contraindication to magnetic stimulation, unability to accept the study
Sites / Locations
- Rouen Universty Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
electrical stimulation
Arm Description
stroke patients
Outcomes
Primary Outcome Measures
videofluoroscopy
measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
Secondary Outcome Measures
Full Information
NCT ID
NCT01345890
First Posted
February 17, 2009
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01345890
Brief Title
Cortical Neuromodulation in Post Stroke Dysphagia
Official Title
Neuromodulation in Post Stroke Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
swallowing, stroke, aspiration, human, electrical stimulation, post stroke dysphagia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electrical stimulation
Arm Type
Experimental
Arm Description
stroke patients
Intervention Type
Procedure
Intervention Name(s)
electrical stimulation
Intervention Description
sub motor threshold stimulation of mylohyoid muscles
Primary Outcome Measure Information:
Title
videofluoroscopy
Description
measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
Time Frame
before and after (once a day for 5 consecutive days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post stroke dysphagia
Exclusion Criteria:
contraindication to magnetic stimulation, unability to accept the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERIN, MD-PhD
Organizational Affiliation
Rouen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen Universty Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cortical Neuromodulation in Post Stroke Dysphagia
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