Effects of Transcranial Alternating Current Stimulation(tACS) Combined With Computerized Cognitive Training for Patients With Mild Cognitive Impairment(MCI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 195
- Locations
- 2
- Primary Endpoint
- Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.
- Last Updated
- 3 years ago
Overview
Brief Summary
This goal of this study is to explore the effects of transcranial alternating current stimulation(tACS) combined with computerized cognitive training(CCT) on improving cognition for patients with mild cognitive impairment(MCI). The study will recruit 195 patients with MCI. Participants will undergo baseline cognitve assessment, EEG and structural and functional MRI. Participants will be randomized to active tACS+CCT group, sham tACS+CCT group and active tACS+sham CCT group. At the end of the intervention, 3-month, 6-month and 12-month follow-up, all subjects will repeat the baseline assessments.
Detailed Description
tACS is a non-invasive brain stimulation technique that uses a low-intensity alternating current (1 to 2 mA) to apply a sinusoidal current to the scalp, directly interacting with the oscillating cortical activity at a given frequency with a given stimulus intensity. Studies have shown that simultaneous tACS on the left prefrontal lobe and left temporal lobe can significantly improve working memory in healthy older adults. The 40 Hz tACS is gamma oscillation, and more and more studies have pointed out that gamma oscillation regulation disorder is associated with impaired working memory function.CCT can improve the cognition in patients with MCI. We hypothesized that tACS combined with CCT can produce synergistic effects in sensitive brain areas.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1)age ≥ 60 years old with memory impairment; (2) the memory test scores are lower 1.5 SD than the normal control; (3) in addition to memory impairment, other cognitive functions remain relatively intact or only slightly impaired; (4) normal daily living ability; (5) can not reach the diagnostic criteria for dementia, Clinical Dementia Rating (CDR) is 0.5
Exclusion Criteria
- •(1) serious medical diseases such as hypertension, heart disease, severe liver disease, etc.; (2) central nervous system diseases such as cerebrovascular diseases, infectious encephalopathy, brain tumors, etc.; (3) severe depression, schizophrenia and patients who have taken psychotropic substances for a long time; (4) Alzheimer's disease and vascular dementia; (5) history of alcohol dependence and other psychoactive substance abuse; (6) patients with contraindications for magnetic resonance imaging; (7) cannot complete the cognitive function tests for various conditions
Outcomes
Primary Outcomes
Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.
Time Frame: up to 3 months(end of the intervention)
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).CWST mainly can examine the executive function. Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.Executive function will be assessed by Trails Making Task.
Neuroimage change from baseline Magnetic Resonance Imaging (MRI)
Time Frame: up to 3 months(end of the intervention)
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
changes in Gamma oscillation intensity (40-80 Hz) over DLPFC
Time Frame: up to 3 months(end of the intervention)
measured by electroencephalogram (EEG)
Secondary Outcomes
- Changes from baseline RBANS(3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Changes from baseline Visual Reasoning(3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Changes from baseline in Geriatric Anxiety Inventory (GAI)(up to 3 months(end of the intervention),3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Changes from baseline Color Word Stroop Test (CWST)(3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Changes from baseline Trails Making Task(3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Changes from baseline Geriatric Depression Scale (GDS)(up to 3 months(end of the intervention),3 months after the end of the intervention,6 months after the end of the intervention and 12 month after the end of the intervention)
- Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)(6 months after the end of the intervention and 12 month after the end of the intervention)
- Side-effects of tACS(At each stimulation session,up to 3 months.)