Mild Cognitive Impairment
Conditions
Keywords
Transcranial Alternating Current Stimulation, Computerized Cognitive Training
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.
Interventions
DEVICETranscranial Alternating Current Stimulation
Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.
BEHAVIORALCognitive Training
Cognitive training includes memory, reasoning, processing speed and role playing, etc.
Sponsors
Yangpu District Central Hospital Affiliated to Tongji University
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task. | 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) | 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 | up to 3 months(end of the intervention) | measured by electroencephalogram (EEG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Executive function will be assessed by Trails Making Task. |
| 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 | The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome. |
| 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 | Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). |
| 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 | Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI) |
| Side-effects of tACS | At each stimulation session,up to 3 months. | — |
| 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 | Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms. |
| 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 | CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated. |
| 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 | Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test. |
Countries
China
Outcome results
None listed