Cortical Neuromodulation in Post Stroke Dysphagia

June 17, 2013 updated by: University Hospital, Rouen

Neuromodulation in Post Stroke Dysphagia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Rouen Universty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post stroke dysphagia

Exclusion Criteria:

  • contraindication to magnetic stimulation, unability to accept the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electrical stimulation
stroke patients
Procedure: electrical stimulation
sub motor threshold stimulation of mylohyoid muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
videofluoroscopy
Time Frame: before and after (once a day for 5 consecutive days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Eric VERIN, MD-PhD, Rouen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/008/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dysphagia

Clinical Trials on electrical stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe