The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.
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.
- Eldith DC-STIMULATOR Device
Intervention Desc: 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 ARM 1: Kind: Experimental Label: Eldith DC-STIMULATOR group Description: 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)
- Sham Eldith DC-STIMULATOR Device
ARM 1: Kind: Experimental Label: sham-Eldith DC-STIMULATOR group Description: Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)
- Allocation: Randomized
- Masking: Double Blind (Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)||up to 60 sec||No|
|Secondary||American Speech-LanguageHearing Association(ASHA)-Norms||up to 2 weeks after tDCS||No|
|Secondary||Korean Version of Modified Barthel Index(K-MBI)||up to 2 weeks after tDCS||No|
|Secondary||Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing||2 weeks after tDCS||No|