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A exploratory study for compliance and validation of Neurofeedback in mild cognitive impairment

Status Approved

  • First Submitted Date

    2018/11/07

  • Registered Date

    2019/01/16

  • Last Updated Date

    2018/12/05

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003433
    Unique Protocol ID DJDSKH-18-BM-12
    Public/Brief Title A exploratory study for compliance and validation of Neurofeedback in mild cognitive impairment
    Scientific Title A exploratory study for compliance and validation of Neurofeedback in mild cognitive impairment
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DJDSKH-18-BM-12
    Approval Date 2018-07-04
    Institutional Review Board Name Institutional Reveiw Board Dunsan Korea Medicine Hospital
    Institutional Review Board Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-470-9488
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Horyong Yoo
    Title Professor
    Telephone +82-42-470-9131
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon
    Contact Person for Public Queries
    Name Jung-Hee Jang
    Title Researcher
    Telephone +82-42-470-9490
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon
    Contact Person for Updating Information
    Name Jung-Hee Jang
    Title Researcher
    Telephone +82-42-470-9490
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-10-01 Actual
    Target Number of Participant 5
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2018-10-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: To evaluate compliance and validation of the neurofeedback training in patients with mild cognitive impairment, and to identify hemodynamic change on cerebral cortical using f-NIRS.
    Background: The importance of prevention, treatment and management of geriatric diseases, especially dementia, is increasing according to aging. Neurofeedback is a training method that measures brain waves and selectively feeds back to brain to improve your homeostasis. This training can improve emotional, behavioral, learning, and health have. Recently, neurofeedback training for dementia patients and healthy people has been reported to improve brain activation. In this study, we aimed to evaluate the effectiveness of neurofeedback in patients with mild cognitive impairment, a pre-dementia stage.
    Clinical study plan: This is an exploratory study to evaluate cognitive function improvement and cerebral hemodynamic change in 5 patients with mild cognitive impairment by performing neurofeedback training twice a week and 16 times for 8 weeks.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Medical Device  
    Intervention Description
    Neurofeedback was performed through a single-channel EEG signal measurement of the dorsolateral prefrontal cortex (dlPFC) (Thought Technology Ltd.'s Neurofeedback). Previous research reported that patients with mild cognitive impairment had reduced alpha-waves (8 to 10.5 Hz) in the prefrontal cortex compared to healthy controls. In this study, the respiration method to regulate the EEG activity of the brain region of interest is divided into concentrating on the nascent, concentrating on the drinking, and concentrating on the subject's autonomous breathing. One session of neurofeedback consists of 5 minutes, which is repeated 9 times. Subjects perform neurofeedback using breathing methods that were instructed by the experimenter.
     In order to measure the respiration rate volume of the subject, respiratory of subject record by belt. Subjects were asked to measure the mean state of the EEG band before and during the neurofeedback session in a relaxed state (~ 30 seconds, natural respiration in a comfortable posture, open eyes and no visual stimulation) and set the threshold value. In the subsequent neurofeedback session, the threshold value of the next session is set according to the feedback level of the subject.
    Number of Arms 1
    Arm 1

    Arm Label

    Training group

    Target Number of Participant

    5

    Arm Type

    Experimental

    Arm Description

    Neurofeedback was performed through a single-channel EEG signal measurement of the dorsolateral prefrontal cortex (dlPFC) (Thought Technology Ltd.'s Neurofeedback). Previous research reported that patients with mild cognitive impairment had reduced alpha-waves (8 to 10.5 Hz) in the prefrontal cortex compared to healthy controls. In this study, the respiration method to regulate the EEG activity of the brain region of interest is divided into concentrating on the nascent, concentrating on the drinking, and concentrating on the subject's autonomous breathing. One session of neurofeedback consists of 5 minutes, which is repeated 9 times. Subjects perform neurofeedback using breathing methods that were instructed by the experimenter.
     In order to measure the respiration rate volume of the subject, respiratory of subject record by belt. Subjects were asked to measure the mean state of the EEG band before and during the neurofeedback session in a relaxed state (~ 30 seconds, natural respiration in a comfortable posture, open eyes and no visual stimulation) and set the threshold value. In the subsequent neurofeedback session, the threshold value of the next session is set according to the feedback level of the subject.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F06.7)Mild cognitive disorder 

    Cognitive Dysfunction
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    40Year~80Year

    Description

    - Individuals 40 to 80 years of age
    - Those who understand the purpose of the study and consent to participate
    - at least 6 years of education
    - Individuals who meet the Peterson diagnostic criteria for MCI with memory problems at least for 3 months
    - Hachinski ischemic score ≤ 6
    - Korean version of the Montreal Cognitive Assessment (MoCA-K) score ≤ 22;
    Exclusion Criteria
    - Diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
    - History of neurological disorder(s) that can cause cognitive decline (e.g., Parkinson's disease, stroke, cerebral hemorrhage, tumors, normal pressure hydrocephalus)
    - Received any treatment for MCI during the previous 2 weeks
    - Involved in other clinical trials within the previous 4 weeks
    - Individuals likely to exhibit a non-cooperative attitude or judged by the researchers to be unable to proceed with the study
    - Individuals who cannot undergo fNIRS measurements for any reason
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    MoCA-K (Korean version of Montreal Cognitive Assessment)
    Timepoint
    baseline, visit8, visit16
    Secondary Outcome(s) 1
    Outcome
    BDI (Beck Depression Inventory)
    Timepoint
    visit1, visit8, visit16
    Secondary Outcome(s) 2
    Outcome
    CNS vital sign (computerized neurocognitive assessment vital sign)
    Timepoint
    visit1, visit16
    Secondary Outcome(s) 3
    Outcome
    Hemodynamic change during working memory in prefrontal cortex
    Timepoint
    visit1, visit16
    Secondary Outcome(s) 4
    Outcome
    Accuracy of working memory
    Timepoint
    visit1, visit16
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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