Back to resultsEffects of tACS Combined With CCT for Patients With MCI
Primary Purpose
Mild Cognitive Impairment
Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial Alternating Current Stimulation
Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Transcranial Alternating Current Stimulation, Computerized Cognitive Training
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
Sites / Locations
- Shanghai Mental Health Center
- Yangpu District Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Sham Comparator
Arm Label
active tACS+ Cognitive Training group
sham tACS+Cognitive Training group
active tACS+ sham Cognitive Training group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Neuroimage change from baseline Magnetic Resonance Imaging (MRI)
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
measured by electroencephalogram (EEG)
Secondary Outcome Measures
Changes from baseline RBANS
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).
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.
Changes from baseline Visual Reasoning
Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.
Changes from baseline Trails Making Task
Executive function will be assessed by Trails Making Task.
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.
Changes from baseline in Geriatric Anxiety Inventory (GAI)
Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms.
Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
Side-effects of tACS
Full Information
NCT ID
NCT04135742
First Posted
October 20, 2019
Last Updated
May 5, 2022
Sponsor
Shanghai Mental Health Center
Collaborators
Yangpu District Central Hospital Affiliated to Tongji University
1. Study Identification
Unique Protocol Identification Number
NCT04135742
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Yangpu District Central Hospital Affiliated to Tongji University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Transcranial Alternating Current Stimulation, Computerized Cognitive Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tACS+ Cognitive Training group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham tACS+Cognitive Training group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
active tACS+ sham Cognitive Training group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Alternating Current Stimulation
Intervention Description
Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Cognitive training includes memory, reasoning, processing speed and role playing, etc.
Primary Outcome Measure Information:
Title
Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task.
Description
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)
Title
Neuroimage change from baseline Magnetic Resonance Imaging (MRI)
Description
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)
Title
changes in Gamma oscillation intensity (40-80 Hz) over DLPFC
Description
measured by electroencephalogram (EEG)
Time Frame
up to 3 months(end of the intervention)
Secondary Outcome Measure Information:
Title
Changes from baseline RBANS
Description
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
Title
Changes from baseline Color Word Stroop Test (CWST)
Description
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
Title
Changes from baseline Visual Reasoning
Description
Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.
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
Title
Changes from baseline Trails Making Task
Description
Executive function will be assessed by Trails Making Task.
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
Title
Changes from baseline Geriatric Depression Scale (GDS)
Description
The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.
Time Frame
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
Title
Changes from baseline in Geriatric Anxiety Inventory (GAI)
Description
Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms.
Time Frame
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
Title
Neuroimage changes from baseline Magnetic Resonance Imaging (MRI)
Description
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
Time Frame
6 months after the end of the intervention and 12 month after the end of the intervention
Title
Side-effects of tACS
Time Frame
At each stimulation session,up to 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunbo Li, Ph.D
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Yangpu District Central Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of tACS Combined With CCT for Patients With MCI
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