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NCT01081444 Clinical Trial

Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia

Stroke Clinical Trial

— rTMS AVC  

Official title:
Effect of Pharyngeal Inhibition Induced by Repetitive Transcranial Stimulation in Post Stroke Dysphagia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01081444
Other study ID # 2007/122/HP
Secondary ID
Status Completed
Phase Phase 4
First received August 14, 2009
Last updated March 22, 2012
Start date March 2009
Est. completion date October 2011

Study information
Verified date March 2012
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve patients with post stroke dysphagia.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- dysphagia

- first episode of stroke

Exclusion Criteria:

- swallowing disorder before stroke

- previous episode of stroke

- MMS < 20 no consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• rTMS
effective and active cortical magnetic stimulations
• Placebo rTMS
non active cortical magnetic stimulation

Locations
Country Name City State
France Physiology, Rouen University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Videofluoroscopy and high resolution manometry day 0, day 14, day 30, day45 No
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