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Effects of tACS Combined With CCT for Patients With MCI

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ClinicalTrials.gov Identifier: NCT04135742
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Yangpu District Central Hospital Affiliated to Tongji University
Information provided by (Responsible Party):
Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcranial Alternating Current Stimulation Behavioral: Cognitive Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Alternating Current Stimulation(tACS) Combined With Computerized Cognitive Training for Patients With Mild Cognitive Impairment(MCI)
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline RBANS, Color Word Stroop Test (CWST),Visual Reasoning and Trails Making Task. [ Time Frame: up to 3 months(end of the intervention) ]
    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.

  2. Neuroimage change from baseline Magnetic Resonance Imaging (MRI) [ Time Frame: up to 3 months(end of the intervention) ]
    Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

  3. changes in Gamma oscillation intensity (40-80 Hz) over DLPFC [ Time Frame: up to 3 months(end of the intervention) ]
    measured by electroencephalogram (EEG)


Secondary Outcome Measures :
  1. Changes from baseline 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 ]
    Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS).

  2. Changes from baseline Color Word Stroop Test (CWST) [ 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 ]
    CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.

  3. Changes from baseline Visual Reasoning [ 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 ]
    Visual Reasoning will be assessed by the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test.

  4. Changes from baseline 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 ]
    Executive function will be assessed by Trails Making Task.

  5. Changes from baseline Geriatric Depression Scale (GDS) [ 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 ]
    The Geriatric Depression Scale will be used to measure neuropsychiatric symptoms. It ranges from 0 to 30, and higher value represents a worse outcome.

  6. Changes from baseline in Geriatric Anxiety Inventory (GAI) [ 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 ]
    Geriatric Anxiety Inventory (GAI) will be used to measure neuropsychiatric symptoms.

  7. Neuroimage changes from baseline Magnetic Resonance Imaging (MRI) [ Time Frame: 6 months after the end of the intervention and 12 month after the end of the intervention ]
    Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

  8. Side-effects of tACS [ Time Frame: At each stimulation session,up to 3 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135742


Contacts
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Contact: Chunbo Li, Ph.D 86-21-34773243 chunbo_li@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Chunbo Li, M.D.    86-21-34773243    chunbo_li@163.com   
Principal Investigator: Chunbo Li, M.D.         
China
Yangpu District Central Hospital Recruiting
Shanghai, China
Contact: Nannan Gu    13120815779    gnnsjtu@163.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Yangpu District Central Hospital Affiliated to Tongji University
Investigators
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Principal Investigator: Chunbo Li, Ph.D Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04135742    
Other Study ID Numbers: 2019-24R
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
Transcranial Alternating Current Stimulation
Computerized Cognitive Training
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders