Mild Cognitive Impairment
Conditions
Keywords
transcranial direct current stimulation, tDCS, Mild Cognitive Impairment, MCI
Brief summary
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
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.
Interventions
DEVICEYBand (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)
DEVICEsham-YBand (YDT-201N)
transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Sponsors
Ybrain Inc.
Incheon St.Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PET-CT images | from baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in activities of daily living | from baseline to Week 12 | Measured by B-ADL |
| Change in Geriatric Depression Scale | from baseline to Week 12 | — |
| Change in Cognitive function | from baseline to Week 12 | Measured by SNSB |
Countries
South Korea
Outcome results
None listed