Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Transcranial direct current stimulation

Sham stimulation

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation, stroke-related dysphagia, cortical plasticity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Neurology, University of Muenster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial direct current stimulation

Sham stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score

Secondary Outcome Measures

Diet at discharge

Dysphagia Severity Rating Score

Endoscopically assessed swallow function

Improvement of salient endoscopic findings

Full Information

NCT ID

NCT01970384

First Posted

October 22, 2013

Last Updated

October 12, 2015

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT01970384

Brief Title

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Official Title

Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Muenster

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Dysphagia

Keywords

transcranial direct current stimulation, stroke-related dysphagia, cortical plasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial direct current stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Other Intervention Name(s)

tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham stimulation

Other Intervention Name(s)

sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score

Time Frame

Within three days after the last stimulation session

Secondary Outcome Measure Information:

Title

Diet at discharge

Time Frame

by the time of discharge, an expected average of 2 weeks after the last stimulation session

Title

Dysphagia Severity Rating Score

Time Frame

within three days after the last stimulation session

Title

Endoscopically assessed swallow function

Description

Improvement of salient endoscopic findings

Time Frame

within three days after the last stimulation session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rainer Dziewas, PhD

Organizational Affiliation

Department of Neurology, University of Muenster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurology, University of Muenster

City

Muenster

ZIP/Postal Code

48129

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23800793

Citation

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.

Results Reference

background

PubMed Identifier

18511871

Citation

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.

Results Reference

background

Stroke, Dysphagia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial