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Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970384
First Posted: October 28, 2013
Last Update Posted: October 14, 2015
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 Muenster
  Purpose
The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.

Condition Intervention
Stroke Dysphagia Device: Transcranial direct current stimulation Device: Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score [ Time Frame: Within three days after the last stimulation session ]

Secondary Outcome Measures:
  • Diet at discharge [ Time Frame: by the time of discharge, an expected average of 2 weeks after the last stimulation session ]
  • Dysphagia Severity Rating Score [ Time Frame: within three days after the last stimulation session ]
  • Endoscopically assessed swallow function [ Time Frame: within three days after the last stimulation session ]
    Improvement of salient endoscopic findings


Enrollment: 60
Study Start Date: June 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial direct current stimulation
20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Device: Transcranial direct current stimulation
20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Other Name: tDCS
Sham Comparator: Sham stimulation
20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Device: Sham stimulation
20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Other Name: sham tDCS

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- dysphagia due to acute stroke

Exclusion Criteria:

  • preexisting dysphagia
  • comorbidities that can possibly cause dysphagia
  • psychiatric comorbidities
  • pacemaker or other implanted electronic devices
  • inability to give informed 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): NCT01970384


Locations
Germany
Department of Neurology, University of Muenster
Muenster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Rainer Dziewas, PhD Department of Neurology, University of Muenster
  More Information

Publications:
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01970384     History of Changes
Other Study ID Numbers: 2010-140
First Submitted: October 22, 2013
First Posted: October 28, 2013
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by University Hospital Muenster:
transcranial direct current stimulation
stroke-related dysphagia
cortical plasticity

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