Clinical trial NCT04135742: Effects of tACS Combined With CCT for Patients With MCI
Official title: Effects of Transcranial Alternating Current Stimulation(tACS) Combined With Computerized Cognitive Training for Patients With Mild Cognitive Impairment(MCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Transcranial Alternating Current Stimulation
Computerized Cognitive Training
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2019-10-23
Enrollment: 195
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.
timeFrame: up to 3 months(end of the intervention)
measure: Neuroimage change from baseline Magnetic Resonance Imaging (MRI)
timeFrame: up to 3 months(end of the intervention)
measure: changes in Gamma oscillation intensity (40-80 Hz) over DLPFC
timeFrame: up to 3 months(end of the intervention)
Secondary outcomes:
measure: Changes from baseline RBANS
timeFrame: 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
measure: Changes from baseline Color Word Stroop Test (CWST)
timeFrame: 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
measure: Changes from baseline Visual Reasoning
timeFrame: 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
measure: Changes from baseline Trails Making Task
timeFrame: 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
measure: Changes from baseline Geriatric Depression Scale (GDS)
timeFrame: 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
measure: Changes from baseline in Geriatric Anxiety Inventory (GAI)
timeFrame: 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
measure: Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)
timeFrame: 6 months after the end of the intervention and 12 month after the end of the intervention
measure: Side-effects of tACS
timeFrame: At each stimulation session,up to 3 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Yangpu District Central Hospital
Study officials:
affiliation: Shanghai Mental Health Center
name: Chunbo Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: