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NCT01345890 Clinical Trial

Cortical Neuromodulation in Post Stroke Dysphagia

Dysphagia Clinical Trial

Official title:
Neuromodulation in Post Stroke Dysphagia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01345890
Other study ID # 2004/008/HP
Secondary ID
Status Completed
Phase N/A
First received February 17, 2009
Last updated June 17, 2013
Start date January 2007
Est. completion date June 2010

Study information
Verified date June 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

Description:

Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2010
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- post stroke dysphagia

Exclusion Criteria:

- contraindication to magnetic stimulation, unability to accept the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• electrical stimulation
sub motor threshold stimulation of mylohyoid muscles

Locations
Country Name City State
France Rouen Universty 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 measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing before and after (once a day for 5 consecutive days) No
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