Mild Cognition Impairment
Conditions
Interventions
Test group (true stimulation group):he 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 the
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age 50-85 years old (including 50 years old and 85 years old), regardless of gender; (2) Meet the diagnostic criteria of Mild Cognitive Impairment of the International Working Group on Mild Cognitive Impairment : ? Cognitive impairment reported by patients or insiders, or found by experienced clinicians; ? Objective evidence of impairment in one or more cognitive domains (from cognitive tests); (3) complex instrumental activities of daily living may be slightly impaired, but maintain independent activities of daily living; ? The diagnosis of dementia has not been reached (MMSE score according to different education levels: illiterate =17 points, primary school =20 points, secondary school or above =24 points) ; (3) The Montreal Cognitive Assessment (MoCA) score was less than 26 points (excluding 26 points), if the education level was less than 12 years, the MoCA score was less than 25 points (excluding 25 points) ; (4) Voluntarily provide informed consent, understand and accept the duration of the study, and be able and willing to comply with all requirements, including the planned treatment, follow-up, and other study procedures.
Exclusion criteria
Exclusion criteria: Comply with any of the following subjects exclusion criteria, is not into the group of this study: (1) There are serious degeneration disease screening before three years or degeneration disease, dementia such as alzheimer's disease and lewy body dementia, Parkinson's disease dementia, frontal temporal lobe degeneration, vascular dementia, normal pressure hydrocephalus and other diseases, such as traumatic brain injury, infections, immune and metabolic disease, tumor, poisoning, etc.) caused by dementia, etc.; (2) The presence or past of other central nervous system diseases, such as: ? history of transient ischemic attack (TIA), stroke or seizure within 12 months; (2) 12 months with auxiliary examination results indicate significant pathologic findings, including but not limited to: cerebral hemorrhage; Cranial MRI revealed an area of hemosiderin deposition > 1.0cm. Evidence of vasogenic edema; Evidence of cerebral contusion, encephalomalacia (except lacunar infarction), aneurysm, vascular malformation or infectious lesion; Evidence of multiple lacunar infarcts or stroke involving major vascular territories, severe small-vessel disease, or white-matter lesions (white matter hyperintensities of grade 2 or 3); Space-occupying lesions; Brain tumors (except meningiomas or arachnoid cysts with a maximum diameter of less than 1 cm); ? Unstable intracranial infection, Parkinson's disease, epilepsy; (3) Previous craniotomy (except resection of meningioma or arachnoid cyst with maximum diameter less than 1 cm), skull defect, or acute traumatic brain injury; (4) Patients had visual, hearing, language or reading disabilities through medical history inquiry, and were unable to complete treatment and evaluation by researchers; (5) Having or previously suffering from mental diseases or symptoms, such as schizophrenia, bipolar disorder, severe depression or anxiety, severe sleep disorder (PSQI scale score =16), acute delirium, etc. (6) There are important organs (heart, lungs, liver, kidney, etc.) serious insufficiency (such as severe cardiovascular disease within 3 months (hospitalized for myocardial infarction or heart surgery, severe congestive heart failure, myocardial infarction or unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis and aneurysm, etc.), serious lung disease (moderately severe pneumonia, respiratory failure, etc.), hepatic insufficiency , renal insufficiency), malignant tumors, severe autoimmune diseases in the active stage of the disease involving the treatment area, etc., which were judged by the investigators to be unsuitable for participation in this clinical trial. (7) Cognition-related drugs (e.g., nootropic drugs, ergot alkaloids, calcium antagonists, ginkgo biloba extract, cholinesterase inhibitors, ionic glutamate receptor antagonists, etc.) started to be used more than 6 weeks before screening, but planned to change the medication regimen (e.g., drug type, dose, etc.) or discontinue. (8) Cognition-related drugs (such as nootropic drugs, ergot alkaloids, calcium antagonists, ginkgo biloba extract, cholinesterase inhibitors, ionic glutamate receptor antagonists, etc.) had been used for 6 weeks before screening, but had not reached stable use; (9) Within six weeks before screening or planned to use drugs to improve cognitive function during the test, such as promoting intellectual medicine and ergot alkaloids, calcium antagonists, ginkgo biloba extract, cholinesterase inhibitors, ionic glutamate recept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 weeks treatment at the end of the Montreal cognitive assessment scale (MoCA) score changes from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of Montreal Cognitive Assessment (MoCA) scores at 6 and 12 weeks after treatment were compared with baseline;Percentage change (%) from baseline in Montreal Cognitive Assessment (MoCA) score at the end of the 3-week treatment and at weeks 6 and 12 after the end of treatment.;The changes of mini-cognitive assessment (MMSE) scores were compared with baseline at the end of 3 weeks of treatment, 6 weeks and 12 weeks after the end of treatment;Three weeks after the treatment, treatment at the end of week 6 and 12 weeks of alzheimer's disease assessment scale - cognitive part (ADAS - cog) Score changes from baseline;The Pittsburgh Sleep Quality Index (PSQI) scores at the end of the 3-week treatment, the 6th week and the 12th week after the treatment were compared with the baseline The situation;The generalized Anxiety Disorder-7 (GAD-7) scores at the end of 3-week treatment, 6 weeks and 12 weeks after treatment were compared with baseline Situation of change;At the end of 3 weeks treatment, 6 and 12 weeks after treatment with the patient health survey scale - nine (9) PHQ - scoring a baseline Situation of transformation;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactChen Lei
West China Hospital, Sichuan University
Outcome results
None listed