Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Intervention Desc: 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 1: Kind: Experimental
    Label: Transcranial direct current stimulation
    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.
  • Sham stimulation Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sham stimulation
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score Within three days after the last stimulation session No
Secondary Diet at discharge by the time of discharge, an expected average of 2 weeks after the last stimulation session No
Secondary Dysphagia Severity Rating Score within three days after the last stimulation session No
Secondary Endoscopically assessed swallow function within three days after the last stimulation session No

Sponsors