Study of tDCS for Mild Cognitive Impairment

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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A Study for the Short- and Long-term Improvement of Cognitive Function (Evaluated by PET-CT and SNSB) 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 22 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 who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower Subjects who are not dementia of Alzheimer's type Subjects who are right-handed Subjects who are able to read and write Subject or legally responsible caregiver has provided informed consent 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 treatment ischemic attack. Subjects who have neurologic problems on physical examination that cuase 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 Subject 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: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YBand (YDT-201N)<br>transcranial Direct Current Stimulation (tDCS) application 3 days a week for 12 weeks (total of 36 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 3 days a week for 12 weeks (total of 36 applications) | Device: sham-YBand (YDT-201N)<br>* transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PET-CT images |  | from baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, transcranial direct current stimulation, tDCS, Mild Cognitive Impairment