A Study of tDCS for Swallowing Difficulties in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.

Detailed Description
-----------------
120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.

Official Title
-----------------
Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Eldith DC-STIMULATOR
* Device: Sham Eldith DC-STIMULATOR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis Subjects who have cortical or subcortical brain lesion Subjects who was diagnosed as stroke within 6 months Subjects ages from 18years to 80years old Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury Subjects who is possible to receive swallowing function intervention 5 days a week Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver Subjects who had no effect from brain stimulation or electrical stimulation therapy Exclusion Criteria Subjects who have pre-existing and active major neurological disease Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia Subjects who have brain lesion except cortex or subcortex area Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure Subjects who is estimated as not appropriate for the study by the investigators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eldith DC-STIMULATOR group<br>Intervention: 20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications) | Device: Eldith DC-STIMULATOR<br>* Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients tDCS intervention] Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany Stimulation site <Experimental group> Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation<br>|
| Sham Comparator: sham-Eldith DC-STIMULATOR group<br>Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications) | Device: Sham Eldith DC-STIMULATOR<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS) |  | up to 60 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Speech-LanguageHearing Association(ASHA)-Norms | Change in swallowing function | up to 2 weeks after tDCS | 
| Korean Version of Modified Barthel Index(K-MBI) | Change in activity of daily living | up to 2 weeks after tDCS | 
| Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing | Change in swallowing function | 2 weeks after tDCS |