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Completed

NCT Number: NCT01970384

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University of Muenster

Münster, 48129, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 names: tDCS

Sham stimulation

Device

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 names: sham tDCS

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

    Time frame: within three days after the last stimulation session

    Improvement of salient endoscopic findings

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2013
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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