Effects of tACS Combined With CCT for Patients With MCI

NCT04135742 | Unknown DMC

• 1 other identifier: 2019-24R
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Keywords

Transcranial Alternating Current Stimulation; Computerized Cognitive Training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Changes from baseline 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)

  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

  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

  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)

  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

Study Arms (3)

active tACS+ Cognitive Training group

EXPERIMENTAL

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; Behavioral: Cognitive Training

sham tACS+Cognitive Training group

SHAM COMPARATOR

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

active tACS+ sham Cognitive Training group

SHAM COMPARATOR

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

Interventions

Transcranial Alternating Current Stimulation DEVICE

Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.

active tACS+ Cognitive Training group; active tACS+ sham Cognitive Training group

Cognitive Training BEHAVIORAL

Cognitive training includes memory, reasoning, processing speed and role playing, etc.

active tACS+ Cognitive Training group; sham tACS+Cognitive Training group

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator

Study Sites (2)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Yangpu District Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Chunbo Li, Ph.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: November 11, 2019
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)