Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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tDCS sham tDCS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No