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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eldith DC-STIMULATOR group | Experimental | 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 group | Sham Comparator | Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eldith DC-STIMULATOR | Device | Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients tDCS intervention]
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS) | up to 60 sec |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Il Shin, Ph.D. | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | 626-770 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20407308 | Background | Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Sham Eldith DC-STIMULATOR | Device |
|
| up to 2 weeks after tDCS |
| Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing | Change in swallowing function | 2 weeks after tDCS |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |