None listed
Conditions
Interventions
Medical Device : Apply 2.0mA transcranial direct current stimulation (YMS-201B) to the dorsolateral prefrontal cortex one session per day/30 minutes/26 weeks
Sponsors
Ybrain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men or women with 55 = age =90 ? Diagnosis of dementia (neurocognitive disorder) based on DSM-V (Diagnostic and Statistical Manual, fifth edition) or ICD-10(The International Statistical Classification of Diseases and Related Health Problems) ? Mild dementia with 18 = MMSE (Mini Mental State Examination) score < 26 ? CDR (Clinical Dementia rating) global score of 0.5 or 1.0 and CDR-SOB (Sum of Boxes) score of 0.5~4.0 ? No changes on acetylcholinesterase inhibitors (ACEI) or NMDA receptor inhibitor for more than 3 months prior to the study screening date. No changes on other drugs including medication to improve cognitive function (i.e. pregabalin, gabapentin cholinealphocerate) or antidepressant, medication for hypertension, diabetes, hyperlipidemia, thyroid disease for more than 1 month prior to the study screening date. ? Able to read and understand the study consent form and is capable of language proficiency at a level capable of answering the questionnaires ? Have a guardian who can accompany the patient when visiting the hospital during the clinical trial ? Able to voluntarily decide on participation and provide written consent, and can participate in the entire period of the clinical trial
Exclusion criteria
Exclusion criteria: ? History of axis I psychiatric disorders including intellectual disabilities, schizophrenia, alcohol addiction, and bipolar disorder ? History of convulsion within 5 years of the screening ? History of transient ischemic attack or stroke within one year from the screening date or diagnosis of cerebrovascular stenosis, subdural hemorrhage, brain tumor, brain abscess on MRI ? Cerebral damage due to trauma, ischemia, hypoxia, etc. ? Who have been admitted to the hospital for mental illness within 5 years of the screening date ? Who have abused drugs within 5 years of the screening date ? Who have been treated for alcohol addiction within 5 years from the screening date ? Difficulty reading the text even with glasses due to decreased vision ? Difficulty hearing even with hearing aid due to hearing impairment ? Difficulty breathing while sitting still ? Suicide attempt within 6 months of the screening date ? Problems with electroencephalograms and transcranial direct current stimulation electrodes due to scalp deformities, inflammatory reactions, or other skin problems ? Contraindication to tDCS (i.e. metal implant in the head) ? Who participated in other clinical trials within 30 days from the screening date ? Women of childbearing potential who do not consent to using contraception* in a medically acceptable manner during this trial (*Medically accepted contraceptive methods: condoms, oral contraception for at least 3 months or more, using injectable or injectable contraceptives, installing intrauterine contraceptives, etc.) ? Pregnant or breastfeeding ? In addition to the above, those who are judged to be inadequate for participating in the clinical trial by a principal investigator or the person in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in K-MMSE (Mini Mental State Examination) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Korean-Instrumental Activities of Daily Living (K-IADL) score;Changes in Clinical Dementia rating (CDR) score;Changes in SVLT-E(Seoul Verbal Leaning Test-Elderly’s version) score;Changes in RCFT(Ray Complex Figure Test) score;Changes in K-CWST(Korean-Color Word Stroop Test) score;Changes in DST(Digit Span Test-Forward/Backward) score;Changes in COWAT(Controlled Oral Word Association Test) score;Changes in K-BNT(Korean-Boston Naming Test) score;Changes in SGDS(Short Version of the Geriatric Depression Scale) score;Changes in GDS(Global Deterioration Scale) score;Changes in MoCA-K (Korean version of Montreal Cognitive Assessment) score;Changes in NPI(Neuropsychiatric Inventory) score;Changes in Quality of life-AD (QoL-AD) score;Changes in Family Quality of life-Dementia (FQoL-D) score;Changes in Alzheimer's Disease Assessment Scale-Cog 11 (ADAS-Cog 11) score;Safety evaluation variables (lab tests, vital signs and physical examination, concomitant medication);regional cerebral glucose metabolism assessed by brain FDG-PET (18F-fludeoxyglucose positron emission tomography) results;Safety evaluation variables (adverse events) | — |
Countries
Korea, Republic of
Contacts
Public ContactYong-An Chung
The Catholic University of Korea
Outcome results
None listed