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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01970384
Other study ID # 2010-140
Secondary ID
Status Completed
Phase N/A
First received October 22, 2013
Last updated October 12, 2015
Start date June 2012
Est. completion date December 2014

Study information

Verified date October 2015
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Germany Department of Neurology, University of Muenster Muenster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Dziewas R, Warnecke T, Olenberg S, Teismann I, Zimmermann J, Kramer C, Ritter M, Ringelstein EB, Schabitz WR. Towards a basic endoscopic assessment of swallowing in acute stroke - development and evaluation of a simple dysphagia score. Cerebrovasc Dis. 2008;26(1):41-7. doi: 10.1159/000135652. Epub 2008 May 30. — View Citation

Suntrup S, Teismann I, Wollbrink A, Winkels M, Warnecke T, Flöel A, Pantev C, Dziewas R. Magnetoencephalographic evidence for the modulation of cortical swallowing processing by transcranial direct current stimulation. Neuroimage. 2013 Dec;83:346-54. doi: 10.1016/j.neuroimage.2013.06.055. Epub 2013 Jun 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score Within three days after the last stimulation session No
Secondary Diet at discharge by the time of discharge, an expected average of 2 weeks after the last stimulation session No
Secondary Dysphagia Severity Rating Score within three days after the last stimulation session No
Secondary Endoscopically assessed swallow function Improvement of salient endoscopic findings within three days after the last stimulation session No
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