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

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ClinicalTrials.gov Identifier: NCT01081444
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Dysphagia Stroke Device: rTMS Device: Placebo rTMS Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pharyngeal Inhibition Induced by Repetitive Transcranial Stimulation in Post Stroke Dysphagia
Study Start Date : March 2009
Primary Completion Date : April 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Active rTMS
Device: rTMS
effective and active cortical magnetic stimulations
Placebo Comparator: 2
sham rTMS
Device: Placebo rTMS
non active cortical magnetic stimulation

Primary Outcome Measures :
  1. Videofluoroscopy and high resolution manometry [ Time Frame: day 0, day 14, day 30, day45 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • dysphagia
  • first episode of stroke

Exclusion Criteria:

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

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): NCT01081444

Physiology, Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Eric VERIN, MD-PhD Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01081444     History of Changes
Other Study ID Numbers: 2007/122/HP
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by University Hospital, Rouen:
repetitive transcranial stimulation

Additional relevant MeSH terms:
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