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Stroke | Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Stroke research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stroke

Dysphagia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Transcranial direct current stimulation20 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:Sham stimulation20 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Transcranial direct current stimulation20 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 stimulation20 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.

Study Status

Completed

Start Date: June 2012

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score

Secondary Outcome: Diet at discharge

Study sponsors, principal investigator, and references

Principal Investigator: Rainer Dziewas, PhD

Lead Sponsor: University Hospital Muenster

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01970384

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.

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