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CompletedNCT01970384Updated Oct 14, 2015

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

An interventional study of Transcranial direct current stimulation and Sham stimulation in Stroke and Dysphagia, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Dysphagia

Keywords

  • transcranial direct current stimulation
  • stroke-related dysphagia
  • cortical plasticity
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • dysphagia due to acute stroke

Exclusion criteria

Exclusion Criteria:

  • preexisting dysphagia
  • comorbidities that can possibly cause dysphagia
  • psychiatric comorbidities
  • pacemaker or other implanted electronic devices
  • inability to give informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceTranscranial 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.

    Also known as: tDCS

  • DeviceSham 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.

    Also known as: sham tDCS

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What researchers measure

Primary outcomes

  1. FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score

    Time frame: Within three days after the last stimulation session

Secondary outcomes

  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

    Improvement of salient endoscopic findings

    Time frame: within three days after the last stimulation session

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Study locations

1 site
  • Department of Neurology, University of Muenster
    Muenster, 48129, Germany
08

References and documents

Publications

  • Suntrup S, Teismann I, Wollbrink A, Winkels M, Warnecke T, Floel 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. PubMed 23800793 ↗
  • 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. PubMed 18511871 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01970384
Lead sponsor
University Hospital Muenster
Responsible party
Sponsor
First posted
Oct 28, 2013
Start date
Jun 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Oct 14, 2015

Study contacts

Rainer Dziewas, PhD
principal investigator · Department of Neurology, University of Muenster

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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