Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Stroke Clinical Trial

Official title:

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970384
• Other study ID #: 2010-140
• 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

• Deglutition Disorders
• Dysphagia
• Stroke

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