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Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

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ClinicalTrials.gov Identifier: NCT01970384
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Dysphagia Device: Transcranial direct current stimulation Device: Sham stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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



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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

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

Publications:
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01970384     History of Changes
Other Study ID Numbers: 2010-140
First Posted: October 28, 2013    Key Record Dates
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