Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Not Applicable

Completed

• Conditions: Stroke; Dysphagia
• Interventions: Device: Sham stimulation; Device: Transcranial direct current stimulation

• Registration Number: NCT01970384
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	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.
Transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score	Within three days after the last stimulation session

Secondary Outcome Measures

Name	Time	Method
Diet at discharge	by the time of discharge, an expected average of 2 weeks after the last stimulation session
Dysphagia Severity Rating Score	within three days after the last stimulation session
Endoscopically assessed swallow function	within three days after the last stimulation session	Improvement of salient endoscopic findings

Trial Locations

Locations (1)

Department of Neurology, University of Muenster; 🇩🇪 Muenster, Germany