Effects of tACS Combined With CCT for Patients With MCI

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Transcranial Alternating Current Stimulation; Behavioral: Cognitive Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Yangpu District Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tACS+ Cognitive Training group; Subjects will receive CCT for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The active tACS group will be stimulated with a 2 mA,40Hz current for 20 minutes each time during the stimulation.	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.
Sham Comparator: sham tACS+Cognitive Training group; Subjects will receive CCT for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The sham tACS group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.	Behavioral: Cognitive Training; Cognitive training includes memory, reasoning, processing speed and role playing, etc.
Sham Comparator: active tACS+ sham Cognitive Training group; Subjects will watch neutral pictures on iPad for a period of 3 months, 24 times, twice a week for 20 minutes each time. Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P4). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have 24 tACS sessions for three months, twice a week.The active tACS group will be stimulated with a 2 mA,40Hz current for 20 minutes each time during the stimulation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
changes in Gamma oscillation intensity (40-80 Hz) over DLPFC	measured by electroencephalogram (EEG)	up to 3 months(end of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Side-effects of tACS		At each stimulation session,up to 3 months.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Yangpu District Central Hospital Affiliated to Tongji University
• Investigators: Principal Investigator: Chunbo Li, Ph.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Computerized Cognitive Training; Transcranial Alternating Current Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2019-24R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No