Records View

Randomized Controlled, Double-blinded, Active-controlled designed clinical trial evaluating The effects of cranial electrotherapy stimulation(CES) in treatment anxiety and stress.

Status Approved

  • First Submitted Date

    2019/06/11

  • Registered Date

    2019/06/14

  • Last Updated Date

    2019/06/14

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
    KCT0004065
    Unique Protocol ID 2016-66
    Public/Brief Title Clinical trials evaluating the effect of cranial electrotherapy stimulation (CES) for anxiety and stress reduction
    Scientific Title Randomized Controlled, Double-blinded, Active-controlled designed clinical trial evaluating The effects of cranial electrotherapy stimulation(CES) in treatment anxiety and stress.
    Acronym cranial electrotherapy stimulation (CES)
    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 2016-66
    Approval Date 2016-08-17
    Institutional Review Board Name Chuncheon Sacred Heart Hospital Institusional Review Board/Ethics Committee
    Institutional Review Board Address 77, Sakju-ro, Chuncheon-si, Gangwon-do
    Institutional Review Board Telephone 033-240-5128
    Data Monitoring Committee No
  • 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 Daeyoung Roh
    Title Clin. Assist. Prof.
    Telephone +82-33-240-5739
    Affiliation Hallym University Medical Center- Chuncheon
    Address Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea
    Contact Person for Public Queries
    Name Jiheon Kim
    Title Researcher
    Telephone +82-33-240-5739
    Affiliation Hallym University Medical Center- Chuncheon
    Address Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea
    Contact Person for Updating Information
    Name Daeyoung Roh
    Title Clin. Assist. Prof.
    Telephone +82-33-240-5739
    Affiliation Hallym University Medical Center- Chuncheon
    Address Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea
  • 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 Active, not recruiting
    Date of First Enrollment 2017-02-15 Actual
    Target Number of Participant 60
    Primary Completion Date 2018-10-01 , Actual
    Study Completion Date 2019-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center- Chuncheon
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2017-02-15 ,
  • 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 Hallym University Medical Center- Chuncheon
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University Medical Center- Chuncheon
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Anxiety and stress-related disorders could be improved and return to normal life if they are treated at appropriate time. But most of patients with anxiety and stress-related disorders do not consider visiting hospital or cannot obtain help from mental health professional because they consider their disorders as an emotional status and have a reluctance to visit psychiatry department. If therapeutic apparatus which improve their symptoms in daily life easily are developed, it is possible to improve their symptom and resolve social issue related psychiatric disorder. 
     With high effectiveness and safety, the CES is appropriate technology to develop as therapeutic apparatus that can treat anxiety, depression, sleep disorder, stress-related disorder and cognitive dysfunction. The purpose of this study is to evaluate of effectiveness of the equipment that is developed to miniaturize than other CES equipment and used as therapeutic apparatus that improves the people with anxiety, depression, sleep disorder and stress-related disorder in daily life through connects with other IT equipment. 
     The device provides alternating current with a frequency of 10 Hz and an intensity of 500μA, linked with smartphone recording treatment logs. Stimulation electrodes were placed resembling the in-ear headphone locations so that it can play music in addition to electrical stimulation. At baseline, participants were randomly assigned to active and sham groups, and then at one time, half of each group told music and half did not. 
     Therefore, In this study, we test the effectiveness of the newly developed CES equipment on anxiety and stress-related symptom in people with anxiety and stress. Also, we compare sleep quality, quality of life, depression, suicidality, cognitive function, fatigue and brain waves between treat group and control group.
  • 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
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    Experimental group: 50 minutes of Active CES, once everyday, for 3 weeks. Apply bi-phase pulse below 1mA. For the first application, apply music to half of the group and not the other half 
    Active Comarator group: 50 minutes of Sham control CES, once everyday, for 3 weeks. Maintain current-free state. For the first application, apply music to half of the group and not the other half
    Number of Arms 2
    Arm 1

    Arm Label

    Active CES(Cranial electrotherapy stimulation) Group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    50 minutes of once everyday, for 3 weeks, applies Active CES which is micro-electricity device. participants are educated by the study presenter Before apply Active CES. To prevent dropout of patients due to injury and exhaustion, at least, participants are visited hospital once a week. For the first application, half of the group will listen to classical music and not the other half.
    Arm 2

    Arm Label

    Sham control CES Group

    Target Number of Participant

    30

    Arm Type

    Active comparator

    Arm Description

    50 minutes of once everyday, for 3 weeks, applies Sham control CES. This device looks same with Active CES But not micro-electricity device. For the first application, half of the group will listen to classical music and not the other half.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F41.2)Mixed anxiety and depressive disorder 

    Anxiety Disorder: Persistent and disabling ANXIETY. Stress, Pshychological: Stress wherein emotional factors predominate.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~65Year

    Description

    1) Participants with Anxiety, Stress-relate disorder self-report score higher then four. 
    2) Men and women aged 19 to 65. 
    3) Those who are able to read and understand subject explanations and agreements, and who have the language ability to respond to the questionnaire. 
    4) Those who have voluntarily participated in the clinical trial and have agreed to the written consent of the subject and are able to participate in the entire period of the clinical trial.
    Exclusion Criteria
    1) Except Anxiety disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) dignosed Axis I. 
    2) Primary diagnosis of alcohol or substance abuse 
    3) diagnosed with bipolar or psychotic major depressive disorder 
    4) attempted suicide before 6 months of screening 
    5) A person who is rated at 6 or more in suicidal tendency 
    6) A person judged to have problems with electroencephalography (EEG) or Alternating Current (AC) stimulation electrodes due to deformity of the scalp, inflammation reaction or other dermatological problems. 
    7) Have a contraindication about CES equipment(ex, A metal board is Inserted in the head). 
    8) A history of epilepsy and family history 
    9) Those with serious clinical impairment of cardiovascular, digestive, respiratory, endocrine, and central nervous system 
    10) Those who participated in other clinical trials within 30 days from the screening date 
    11) Female subjects likely to become pregnant 
    12) Pregnant or lactating women 
    13) In addition to the above, persons with clinical symptoms who are judged medically by the person in charge of testing or who are considered inappropriate for this test
    Healthy Volunteers Yes
  • 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
    SRI(Stress Response Instrument)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week
    Primary Outcome(s) 2
    Outcome
    HAM-A(Hamilton Anxiety Rating Scale), STAI(State-Trait Anxiety Inventory)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week
    Secondary Outcome(s) 1
    Outcome
    HAM-D(Hamilton Depression Rating Scale), BDI(Beck Depression Inventory)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week
    Secondary Outcome(s) 2
    Outcome
    Wisconsin Card Sorting Test
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week
    Secondary Outcome(s) 3
    Outcome
    (PQSI)Pittsburgh Sleep Quality Index
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week
    Secondary Outcome(s) 4
    Outcome
    Suicidality Scale
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week
    Secondary Outcome(s) 5
    Outcome
    WHOQOL-BREF(Korean Version of WHO Quality of Life Scale Abbreviated Version)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week
    Secondary Outcome(s) 6
    Outcome
    CGISI(clinician-rated Clinical Global Impression-Severity of Illness scale)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week
    Secondary Outcome(s) 7
    Outcome
    qEEG (quantitative electroencephalography)
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week
    Secondary Outcome(s) 8
    Outcome
    EEG Coherence
    Timepoint
    Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week
  • 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 No
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동