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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081444
First Posted: March 5, 2010
Last Update Posted: March 23, 2012
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 aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.

Condition Intervention Phase
Dysphagia Stroke Device: rTMS Device: Placebo rTMS Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

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

Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

Inclusion Criteria:

  • dysphagia
  • first episode of stroke

Exclusion Criteria:

  • swallowing disorder before stroke
  • previous episode of stroke
  • MMS < 20 no consent
  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): NCT01081444


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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01081444     History of Changes
Other Study ID Numbers: 2007/122/HP
First Submitted: August 14, 2009
First Posted: March 5, 2010
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by University Hospital, Rouen:
repetitive transcranial stimulation

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


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