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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01081444
First received: August 14, 2009
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01081444     History of Changes
Other Study ID Numbers: 2007/122/HP
Study First Received: August 14, 2009
Last Updated: March 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
repetitive transcranial stimulation

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Cerebral Infarction
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 18, 2013