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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 Alzheimer's disease
Twenty 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 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 cognitive function | Measured by ADAS-Cog 11 | 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 cognitive function |
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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 | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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) |
|
Measured by Korean version of Montreal Cognitive Assessment (K-MoCA), Korean version of Mini Mental Status Examination (K-MMSE), and Clinical Dementia Rating - Sum of Boxes(CDR-SOB) |
| from baseline to Week 6 and Week 12 |
| Change in Korean version of Geriatric Depression Scale (K-GDS) | from baseline to Week 6 and Week 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 behavioral symptoms | Measured by Neuropsychiatric Inventory | from baseline to Week 6 and Week 12 |
| Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus) | from baseline to Week 12 |
| Change in tDCS feedback | Measured by tDCS feedback questionnaire | Week 2, 4, 6 and 12 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |