NCT01970384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

October 22, 2013

Last Update Submit

October 12, 2015

Conditions

StrokeDysphagia

Keywords

transcranial direct current stimulationstroke-related dysphagiacortical plasticity

Outcome Measures

Primary Outcomes (1)

  • FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score

    Within three days after the last stimulation session

Secondary Outcomes (3)

  • 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

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

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 stimulation

SHAM COMPARATOR

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

Transcranial direct current stimulationDEVICE

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
Transcranial direct current stimulation
Sham stimulationDEVICE

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
Sham stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- dysphagia due to acute stroke

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University of Muenster

Münster, 48129, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23800793BACKGROUND

  • 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.

    PMID: 18511871BACKGROUND

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Rainer Dziewas, PhD

    Department of Neurology, University of Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 28, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

DE(1)