Back to resultsEffect of Pharyngeal Inhibition by rTMS on Swallowing Function (rTMSvideoSS)
Primary Purpose
Oropharyngeal Dysphagia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Oropharyngeal Dysphagia focused on measuring neuromodulation, swallowing, magnetic stimulation, healthy subjects
Eligibility Criteria
Inclusion Criteria:
- 18-50 years old
- healthy subjects
Exclusion Criteria:
- epilepsia
- brain injury
- stroke
- pregnancy
Sites / Locations
- VERIN
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
rTMS
Placebo
Arm Description
rTMS on pharyngeal cortical area in healthy subjects
Sham rTMS on pharyngeal cortical area in healthy subjects
Outcomes
Primary Outcome Measures
pharyngeal pressure
Swallowing function will be studied before and after rTMS with videomanometry
Secondary Outcome Measures
swallowing time
Swallowing function will be studied before and after rTMS with videomanometry
Full Information
NCT ID
NCT02170454
First Posted
February 17, 2009
Last Updated
June 17, 2014
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02170454
Brief Title
Effect of Pharyngeal Inhibition by rTMS on Swallowing Function
Acronym
rTMSvideoSS
Official Title
Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
June 2009 (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 aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.
Detailed Description
The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on healthy subjects. Swallowing function will be studied before and after rTMS with videomanometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia
Keywords
neuromodulation, swallowing, magnetic stimulation, healthy subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Active Comparator
Arm Description
rTMS on pharyngeal cortical area in healthy subjects
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sham rTMS on pharyngeal cortical area in healthy subjects
Intervention Type
Procedure
Intervention Name(s)
magnetic stimulation
Intervention Description
rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects
Primary Outcome Measure Information:
Title
pharyngeal pressure
Description
Swallowing function will be studied before and after rTMS with videomanometry
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
swallowing time
Description
Swallowing function will be studied before and after rTMS with videomanometry
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-50 years old
healthy subjects
Exclusion Criteria:
epilepsia
brain injury
stroke
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERIN, MDPhD
Organizational Affiliation
Rouen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VERIN
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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Effect of Pharyngeal Inhibition by rTMS on Swallowing Function
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