An interventional study of Yband (YDT-201N) and Sham-Yband (YDT-201N) in Mild Cognitive Impairment, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-03.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 20 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications)
Device: Yband (YDT-201N)
sham-tDCS application 7 days a week for 12 weeks (total of 84 applications)
Device: Sham-Yband (YDT-201N)
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)
tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex
Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13)
Time frame: from baseline to Week 6 and Week 12
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
Time frame: from baseline to Week 12
Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)
Time frame: from baseline to Week 12
Change in tDCS feedback
Measured by tDCS feedback questionnaire
Time frame: 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)
Time frame: from baseline to Week 12
Change in Korean version of Geriatric Depression Scale (K-GDS)
Time frame: 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)
Time frame: from baseline to Week 6 and Week 12
Change in Multifactorial Memory Questionnaire (MMQ)
Time frame: from baseline to Week 6 and Week 12
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center