Mild Cognitive Impairment
Conditions
Interventions
MCI with emotional symptoms – sham tACS group (Substudy 1):sham gamma-band tACS over the precuneus
MCI with emotional symptoms – active tACS group (Substudy 1):active gamma-band tACS over the precuneus
Left DLPFC–precuneus ?–?-tACS group (Substudy 2):Left DLPFC–theta and precuneus-gamma tACS
Left DLPFC–precuneus ?–?-tACS group (Substudy 2):Left DLPFC–theta and precuneus-theta tACS
MCI without emotional symptoms – sham tACS group (Substudy 1):sham gamma-band tACS over the precuneus
Left DLPFC–precuneus sham tACS group (Substudy 2):sham tACS over left DLPFC and precuneus
MCI without emotional symptoms – active tACS group (Substudy 1):active gamma-band tACS over the precuneus
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 55–75 years at baseline. 2. Meeting the Jak/Bondi criteria for mild cognitive impairment (MCI) based on the Alzheimer’s Disease Neuroimaging Initiative (ADNI) in the U.S.: (1) Cognitive complaint: The patient, an informant (like a family member), or a clinician notices changes in cognitive function; (2) Objective cognitive impairment: There is evidence of objective cognitive deficits, usually shown by performance on standardized neuropsychological tests that is 1.0 standard deviation below the normal range for people of the same age and education level; Overall cognitive screening: Montreal Cognitive Assessment Basic version (MoCA-B) scores: education 12 years, MoCA-B 17–24; (3) Daily living ability (ADL) basically normal: Able to independently handle basic daily activities (like dressing, eating, washing). Instrumental activities of daily living (IADL, like managing finances, shopping, taking medication) might have mild difficulties but not severe enough to affect independent living; (4) Does not meet dementia criteria: The overall level of impairment does not meet the diagnostic standards for dementia in the DSM-5 or ICD-11. Clinical staging: Clinical Dementia Rating (CDR) total score (CDR-SB) ranges from 0.5 to 2.0. 3. MCI without emotional symptoms - single-target precuneus gamma-tACS group: GDS-15 score = 9 (substudy 1). 4.Normal or corrected-to-normal vision and hearing, willing to complete all cognitive assessments and comply with all study requirements informed consent form was signed. 5.Right-handed. 6.The patient and their legal guardian/family member willing and capable to give informed consent for participation in the study after it has been thoroughly explained able.
Exclusion criteria
Exclusion criteria: 1. Nervous System Diseases: (1) Dementia with a clear diagnosis, such as Alzheimer's disease (AD), vascular dementia (VaD), Lewy body dementia (DLB), frontotemporal dementia (FTD), etc.; (2) Other central nervous system diseases that may cause cognitive dysfunction, such as cerebrovascular diseases (significant white matter lesions, history of infarction or hemorrhage in critical areas), brain tumors, Parkinson's disease, hydrocephalus, intracranial infections, epilepsy, etc. 2. Mental Disorders: (1) Currently or previously suffering from serious mental illnesses, such as schizophrenia, bipolar disorder, etc.; (2) Currently in a severe depressive episode (for example, Geriatric Depression Scale GDS-15 >=12), or a history of long-term use of psychiatric medications (such as antipsychotics, high-dose antidepressants) with recent dosage adjustments. 3. Physical illnesses and related medical history: (1) Systemic diseases that severely affect brain function, such as uncontrolled thyroid disorders, severe liver or kidney dysfunction, severe vitamin B12 or folate deficiency, etc.; (2) Unstable severe physical illnesses, such as uncontrolled hypertension (systolic =160 mmHg or diastolic =100 mmHg), unstable heart disease, severe diabetes, etc.; (3) History related to the auditory or vestibular system, such as a history of otitis media, Meniere's disease, frequent episodes of vertigo, known use of ototoxic drugs, and a family history of hereditary deafness; (4) Severe vision impairment; (5) History of alcohol or drug abuse/dependence. 4. Contraindications for transcranial alternating current stimulation (tACS): (1) Skin damage, infection, or severe dermatitis on the scalp that would interfere with electrode placement; (2) Intracranial metal implants (such as aneurysm clips, metal stents, shunts, etc.) or electronic devices like pacemakers or cochlear implants; (3) History of seizures; (4) Abnormal sensitivity or fear of electrical stimulation. 5. Others: (1) Physical disabilities, communication, or mobility difficulties that seriously affect the ability to cooperate with the study; (2) Contraindications for MRI scanning (e.g., claustrophobia), if the study protocol includes MRI scans; (3) Inability to complete cognitive tests or tACS intervention procedures as required for any reason; (4) Participation in other clinical drug or interventional studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AVLT score;SWM task score in CANTAB (Substudy 2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Structrual and functional magnetic resonance imaging (MRI) data (Substudy 2);electroencephalography (EEG);Side-effect evaluation;Scores on other CANTAB tasks (Substudy 2);Emotional symptoms (Substudy 1);Autobiographical Memory Test (Substudy 1);The Face-Name Association Test score (Substudy 1); | — |
Countries
China
Contacts
Public ContactXinyi Cao
Shanghai Mental Health Center
Outcome results
None listed