A Pilot Study of tDCS for Mild Cognitive Impairment

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 13) After Transcranial Direct Current Stimulation in Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Yband (YDT-201N)
* Device: Sham-Yband (YDT-201N)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have a subjective memory impairment Subjects who have Korean version of Mini Mental Status Examination score 24 or more Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD Subjects who have had other cognitive impairments besides memory Subjects with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower Subjects who are right-handed Subjects who are able to read and write Both subject and legally responsible caregiver have provided informed consent According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm Exclusion Criteria: Subjects who have a history of stroke and seizures Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a transient ischemic attack. Subjects who have neurologic problems on physical examination that cause memory disturbances Subjects who have a history of DSM-IV Axis I disorders Subjects who have extremely sensitive skin Subjects who have suffered from the cancer in 3 years Subjects who have had a cerebrovascular neurosurgery in medical history Subjects who have dyspnea in sitting position Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack. Subjects who have a history of drug or alcohol abuse (in the past 5 years) Subjects who have a history of mental or emotional disorders (in the past 5 years) Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia Subjects who have a history of hospitalization due to head injury Subjects who are unable to read even with glasses Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YBand (YDT-201N)<br>transcranial Direct Current Stimulation (tDCS) application 7 days a week for 12 weeks (total of 84 applications) | Device: Yband (YDT-201N)<br>* 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)<br>|
| Sham Comparator: sham-YBand (YDT-201N)<br>sham-tDCS application 7 days a week for 12 weeks (total of 84 applications) | Device: Sham-Yband (YDT-201N)<br>* tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog 13) |  | from baseline to Week 6 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, MCI, tDCS, transcranial Direct Current Stimulation