search
Back to results

Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia (rTMS AVC)

Primary Purpose

Dysphagia, Stroke

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
rTMS
Placebo rTMS
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring repetitive transcranial stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • dysphagia
  • first episode of stroke

Exclusion Criteria:

  • swallowing disorder before stroke
  • previous episode of stroke
  • MMS < 20 no consent

Sites / Locations

  • Physiology, Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Active rTMS

sham rTMS

Outcomes

Primary Outcome Measures

Videofluoroscopy and high resolution manometry

Secondary Outcome Measures

Full Information

First Posted
August 14, 2009
Last Updated
March 22, 2012
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT01081444
Brief Title
Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia
Acronym
rTMS AVC
Official Title
Effect of Pharyngeal Inhibition Induced by Repetitive Transcranial Stimulation in Post Stroke Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (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 assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Stroke
Keywords
repetitive transcranial stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Active rTMS
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
sham rTMS
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
effective and active cortical magnetic stimulations
Intervention Type
Device
Intervention Name(s)
Placebo rTMS
Intervention Description
non active cortical magnetic stimulation
Primary Outcome Measure Information:
Title
Videofluoroscopy and high resolution manometry
Time Frame
day 0, day 14, day 30, day45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: dysphagia first episode of stroke Exclusion Criteria: swallowing disorder before stroke previous episode of stroke MMS < 20 no consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric VERIN, MD-PhD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiology, Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia

We'll reach out to this number within 24 hrs