Effects of tACS Combined With CCT for Patients With MCI

Shanghai Mental Health Center195 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

195

Conditions

Mild Cognitive Impairment

Interventions

Transcranial Alternating Current StimulationDEVICE

Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.

Cognitive TrainingBEHAVIORAL

Cognitive training includes memory, reasoning, processing speed and role playing, etc.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (2)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Yangpu District Central Hospital

Shanghai, China

Outcomes

Primary Outcomes

Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.

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.

Time frame: up to 3 months(end of the intervention)

Neuroimage change from baseline Magnetic Resonance Imaging (MRI)

Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

Time frame: up to 3 months(end of the intervention)

changes in Gamma oscillation intensity (40-80 Hz) over DLPFC

measured by electroencephalogram (EEG)

Time frame: up to 3 months(end of the intervention)

Secondary Outcomes

Changes from baseline RBANS

Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).

Time frame: 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)

CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.

Time frame: 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

Data from ClinicalTrials.gov

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