Stroke
Conditions
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.
Interventions
DEVICEEldith DC-STIMULATOR
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
DEVICESham Eldith DC-STIMULATOR
Sponsors
Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS) | up to 60 sec |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Speech-LanguageHearing Association(ASHA)-Norms | up to 2 weeks after tDCS | Change in swallowing function |
| Korean Version of Modified Barthel Index(K-MBI) | up to 2 weeks after tDCS | Change in activity of daily living |
| Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing | 2 weeks after tDCS | Change in swallowing function |
Countries
South Korea
Outcome results
None listed