Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Study Overview
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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.

Official Title
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Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Conditions
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Stroke, Dysphagia

Intervention / Treatment
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* Device: Transcranial direct current stimulation
* Device: Sham stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial direct current stimulation<br>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<br>* 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.<br>* Other names: tDCS;|
| Sham Comparator: Sham stimulation<br>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<br>* 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.<br>* Other names: sham tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score |  | Within three days after the last stimulation session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Improvement of salient endoscopic findings | within three days after the last stimulation session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, stroke-related dysphagia, cortical plasticity