Effects of tACS Combined With CCT for Patients With MCI

Mild Cognitive Impairment Clinical Trial

Official title:

Effects of Transcranial Alternating Current Stimulation(tACS) Combined With Computerized Cognitive Training for Patients With Mild Cognitive Impairment(MCI)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04135742
• Other study ID #: 2019-24R
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 195
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Transcranial 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.

Behavioral:
• Cognitive Training
Cognitive training includes memory, reasoning, processing speed and role playing, etc.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Yangpu District Central Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months(end of the intervention)
Primary	Neuroimage change from baseline Magnetic Resonance Imaging (MRI)	Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)	up to 3 months(end of the intervention)
Primary	changes in Gamma oscillation intensity (40-80 Hz) over DLPFC	measured by electroencephalogram (EEG)	up to 3 months(end of the intervention)
Secondary	Changes from baseline RBANS	Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (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
Secondary	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.	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
Secondary	Changes from baseline Visual Reasoning	Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.	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
Secondary	Changes from baseline Trails Making Task	Executive function will be assessed by 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
Secondary	Changes from baseline Geriatric Depression Scale (GDS)	The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.	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
Secondary	Changes from baseline in Geriatric Anxiety Inventory (GAI)	Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms.	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
Secondary	Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)	Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)	6 months after the end of the intervention and 12 month after the end of the intervention
Secondary	Side-effects of tACS		At each stimulation session,up to 3 months.