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| Name | Class |
|---|---|
| Ybrain Inc. | INDUSTRY |
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The primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)
Twenty patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YBand (YDT-201N) | Experimental | transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications) |
|
| sham-YBand (YDT-201N) | Sham Comparator | sham-tDCS application 7 days a week for 12 weeks (total of 84 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 Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13) | from baseline to Week 6 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in questionnaire | Measured by I-PAQ (International Physical Activity Questionnaire), Quality of Life Scale, KDSQ (Korean Dementia Screening Questionnaire), and Prospective and retrospective memory questionnaire | from baseline to Week 12 |
| Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duk-Lyul Na, MD, PhD | Contact | +82-2-3410-3594 | dukna@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Duk L. Na, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | 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 | tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex |
|
| from baseline to Week 12 |
| Change in tDCS feedback | Measured by tDCS feedback questionnaire | Week 2, 4, 6 and 12 |
| Change in activities of daily living | Measured by Korean version of Bayer ADL (K-ADL) and S-IADL (Seoul-Instrumental Activities of Daily Living score) | from baseline to Week 12 |
| Change in Korean version of Geriatric Depression Scale (K-GDS) | from baseline to Week 6 and Week 12 |
| Change in cognitive function | Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), Clinical Dementia Rating - Sum of Boxes(CDR-SOB), Free and Cued Selective Reminding Test (FCSRT), Cambridge Neuropsychological Test Automated Battery (CANTAB battery), COWAT (Controlled Oral Word Association Test), Stroop test, Digit symbol coding, and Trail making test (TMT) | from baseline to Week 6 and Week 12 |
| Change in Multifactorial Memory Questionnaire (MMQ) | from baseline to Week 6 and Week 12 |