Trial record 15 of 218 for:    Open Studies | "Deglutition Disorders"

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital Muenster
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01970384
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diet at discharge [ Time Frame: by the time of discharge, an expected average of 2 weeks after the last stimulation session ] [ Designated as safety issue: No ]
  • Dysphagia Severity Rating Score [ Time Frame: within three days after the last stimulation session ] [ Designated as safety issue: No ]
  • Endoscopically assessed swallow function [ Time Frame: within three days after the last stimulation session ] [ Designated as safety issue: No ]
    Improvement of salient endoscopic findings


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970384

Contacts
Contact: Rrainer Dziewas +4925183 48172 dziewas@uni-muenster.de

Locations
Germany
Department of Neurology, University of Muenster Recruiting
Muenster, Germany, 48129
Contact: Rainer Dziewas, PhD    +4925183 ext 48172    dziewas@uni-muenster.de   
Principal Investigator: Rainer Dziewas, PhD         
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
Study First Received: October 22, 2013
Last Updated: October 22, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Cerebral Infarction
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014