Mild Cognition Impairment
Conditions
Interventions
Test group (true stimulation group):The stimulation electrode was placed on the left DLPFC (F3) and the right DLPFC (F4). The stimulation intensity was 2mA, the stimulation frequency was 10 Hz, and th
Sponsors
Shanghai Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age = 50 years old, regardless of gender; (2) Meets the diagnostic criteria of the International Working Group on Mild Cognitive Impairment for mild cognitive impairment: ? Patient or informant reports, or experienced clinical physicians discover cognitive impairment; ? Objective evidence of impairment in one or more cognitive domains (from cognitive tests); ? Complex instrumental daily abilities may have minor impairments, but maintaining independent daily living abilities; ? Not yet diagnosed with dementia; (3) The Montreal Cognitive Assessment Scale (MoCA) has a score of 19-25 (including 19 and 25 points); (4) Voluntarily sign an informed consent form, understand and accept the duration of the study, be able and willing to comply with all requirements, including planned treatment, follow-up, and other research procedures.
Exclusion criteria
Exclusion criteria: (1) There are degenerative or non degenerative dementia, such as dementia caused by Alzheimer's disease, dementia with Lewy bodies, dementia with Parkinson's disease, frontotemporal lobar degeneration, vascular dementia, normal pressure hydrocephalus, and other diseases (such as brain injury, infection, immunity, tumor, poisoning, metabolic disease, etc.); (2) The presence or previous suffering from other central nervous system diseases, such as cerebrovascular disease, intracranial tumor, intracranial infection, Parkinson's disease, epilepsy, etc., may affect cognitive function according to the judgment of the investigator; (3) Have received neurosurgical operation or treatment in the past, or have a history of craniocerebral trauma; (4) There are visual, auditory, language or reading disabilities, and the treatment and evaluation cannot be completed; (5) Existing or previous psychiatric diseases or symptoms, such as schizophrenia, bipolar disorder, severe depression or anxiety, delirium, etc; (6) There are serious insufficiency of important organs (heart, lung, liver, kidney, etc.) (such as serious cardiovascular disease (hospitalized due to myocardial infarction or cardiac surgery, congestive heart failure or myocardial infarction within 3 months, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, etc.), serious lung disease (moderate to severe pneumonia, respiratory failure, etc.), liver dysfunction, renal dysfunction) Malignant tumors, autoimmune diseases, etc., are not suitable to participate in this clinical trial according to the judgment of the investigator; (7) Drugs that improve cognitive function (such as intelligence promoting drugs, ergot alkaloids, calcium ion antagonists, Ginkgo biloba extract, cholinesterase inhibitors, ionotropic glutamate receptor antagonists, etc.) have been started and stably used 6 weeks before screening, but the medication plan (such as drug type, dose, etc.) is planned to be changed or stopped during the test; (8) Drugs that improve cognitive function (such as intelligence promoting drugs, ergot alkaloids, calcium ion antagonists, Ginkgo biloba extract, cholinesterase inhibitors, ionotropic glutamate receptor antagonists, etc.) have been used 6 weeks before screening, but have not yet reached stable use; (9) Drugs that improve cognitive function (such as intelligence promoting drugs, ergot alkaloids, calcium antagonists, Ginkgo biloba extract, cholinesterase inhibitors, ionotropic glutamate receptor antagonists, etc.) were used within 6 weeks before screening or planned to be used during the trial; (10) Metal objects or devices (except dental metal implants) have been implanted in the brain or body, such as cardiac pacemaker or defibrillator, drug pump, nerve stimulator, cochlear implant, etc; (11) There is active skin damage or inflammation on the skin where the stimulating electrode contacts, such as herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, etc; (12) Drug abuse or alcohol dependence; (13) Subjects are participating in other clinical trials within 3 months before enrollment in this trial or currently; (14) Other circumstances in which the investigator believes that it is inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Montreal Cognitive Assessment Scale (MoCA) score at the end of treatment compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of MOCA scores compared with baseline at the 3rd, 6th and 12th week after treatment;Changes of Alzheimer's disease assessment scale cognitive component (ADAS COG) score from baseline at the end of treatment, at the 3rd, 6th and 12th week after treatment;Changes of Pittsburgh sleep quality index (PSQI) score compared with baseline at the end of treatment, at the 3rd, 6th and 12th week after treatment;Changes of GAD-7 scores from baseline at the end of treatment, at the 3rd, 6th and 12th week after treatment;Changes of PHQ-9 scores from baseline at the end of treatment, at the 3rd, 6th and 12th week after treatment;Changes of theta frequency energy of EEG compared with baseline at the end of treatment;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactLi Cheng
Shanghai Fourth People's Hospital
Outcome results
None listed