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| Name | Class |
|---|---|
| Ybrain Inc. | INDUSTRY |
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The primary objective of this study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)
Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YBand (YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 applications) |
|
| sham-Yband (YDT-201N) | Sham Comparator | sham-tDCS application 3 days a week for 12 weeks (total of 36 applications) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YBand (YDT-201N) | Device | transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PET-CT images | from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive function | Measured by SNSB | from baseline to Week 12 |
| Change in Cognitive function | Measured by Korean version of Mini Mental Status Examination (K-MMSE) and Clinical Dementia Rating (CDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-An Chung, M.D., Ph.D. | Professor, Department of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon St.Mary's Hospital | Incheon | 403-720 | South Korea |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| sham-YBand (YDT-201N) | Device | transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) |
|
| from baseline to Week 12 |
| Change in activities of daily living | Measured by B-ADL | from baseline to Week 12 |
| Change in Geriatric Depression Scale | from baseline to Week 12 |