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Investigation of the brain pathophysiology of addiction disorder using cerebral glucose metabolism and brain network analysis and evaluation of the treatment effect of neuromodulation

Status Approved

  • First Submitted Date

    2018/02/02

  • Registered Date

    2018/04/23

  • Last Updated Date

    2019/07/08

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    		 KCT0002823
    Unique Protocol ID OC17DNSI0133
    Public/Brief Title Investigation of the brain pathophysiology of addiction disorder and evaluation of the treatment effect of neuromodulation
    Scientific Title Investigation of the brain pathophysiology of addiction disorder using cerebral glucose metabolism and brain network analysis and evaluation of the treatment effect of neuromodulation
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    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 OIRB-신20171110-013
    Approval Date 2017-11-10
    Institutional Review Board Name Incheon St. Mary's Hospital Institutional Review Board
    Institutional Review Board Address 56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea
    Institutional Review Board Telephone 032-280-5371
    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 Jin Kyoung Oh
    Title Associate Professor
    Telephone +82-32-280-5242
    Affiliation The Catholic University of Korea
    Address 56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea
    Contact Person for Public Queries
    Name Hyeonseok Jeong
    Title Research Professor
    Telephone +82-32-280-5254
    Affiliation The Catholic University of Korea, Incheon St. Mary's Hospital
    Address 56, Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea
    Contact Person for Updating Information
    Name Hyeonseok Jeong
    Title Research Professor
    Telephone +82-32-280-5254
    Affiliation The Catholic University of Korea, Incheon St. Mary's Hospital
    Address 56, Dongsu-ro, Bupyeong-gu, Incheon, 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 Recruiting
    Date of First Enrollment 2018-03-22 Actual
    Target Number of Participant 80
    Primary Completion Date 2020-02-29 , Anticipated
    Study Completion Date 2020-02-29 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Incheon St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-03-22 ,

  • 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 National Research Foundation
    Organization Type Government
    Project ID 2017R1C1B2011802

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Incheon St. Mary's Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    In this study, we aim to investigate changes in alcohol use disorder (AUD) symptoms after additionally applying non-invasive transcranial direct current stimulation (tDCS) treatment in AUD patients receiving standard drug therapy or individuals with problematic alcohol drinking. In addition, changes in structural/functional/energy metabolism of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET/CT) will be analyzed and correlations between these changes and changes in symptoms of alcohol use disorder will be examined.

Additionally, we aim to identify changes in emotional symptoms and cognitive function after tDCS treatment in AUD patients receiving standard medication or individuals with problematic alcohol drinking. We will compare the differences in structure, function, and energy metabolism of the brain between the patients and healthy controls in the baseline and analyze the association with alcohol use disorder symptoms.

  • 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 Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Caregiver, Outcome Accessor
    Allocation RCT
    Intervention Type Drug, Medical Device  
    Intervention Description 
    (1) Active transcranial direct current stimulation for patients with alcohol use disorder: standard psychiatric drug treatment for alcohol use disorder and transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex
(2) Sham transcranial direct current stimulation for patients with alcohol use disorder: standard psychiatric drug treatment for alcohol use disorder and sham transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex
(3) Active transcranial direct current stimulation for individuals with problematic drinking: transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex
(4) Sham transcranial direct current stimulation for individuals with problematic drinking: sham transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex
(5) Healthy controls: only baseline assessments including questionnaires, neuroimaging, and cognitive function tests are conducted without transcranial direct current stimulation.
    Number of Arms 5
    Arm 1

    Arm Label

    Active transcranial direct current stimulation for patients with alcohol use disorder

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    Standard psychiatric medication for alcohol use disorders,
transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex (2 mA intensity, 30 min, 3 times per week, 12 times for 4 weeks)
    Arm 2

    Arm Label

    Sham transcranial direct current stimulation for patients with alcohol use disorder

    Target Number of Participant

    20

    Arm Type

    Sham comparator

    Arm Description

    Standard psychiatric medication for alcohol use disorders,
Sham transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex (30 min, 3 times per week, 12 times for 4 weeks)
    Arm 3

    Arm Label

    Healthy controls

    Target Number of Participant

    20

    Arm Type

    No intervention

    Arm Description

    Only baseline assessments including questionnaires, neuroimaging, and cognitive function tests are conducted without intervention.
    Arm 4

    Arm Label

    Active transcranial direct current stimulation for individuals with problematic drinking

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex (2 mA intensity, 30 min, 3 times per week, 12 times for 4 weeks)
    Arm 5

    Arm Label

    Sham transcranial direct current stimulation for individuals with problematic drinking

    Target Number of Participant

    20

    Arm Type

    Sham comparator

    Arm Description

    Sham transcranial direct current stimulation treatment to the dorsolateral prefrontal cortex (30 min, 3 times per week, 12 times for 4 weeks)

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F10.9)Unspecified mental and behavioural disorder due to use of alcohol 

    Alcohol use disorder, problematic drinking
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~60Year

    Description

    [Alcohol use disorder group]
(a) Diagnosed with alcohol use disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5 and taking standard medication, and alcohol abstinence status will be considered.
(b) Adult men and women aged 20 to 60 years

[Problematic drinking group]
(a) More than 4 standard drinks (SD) for one occasion or more than 14 SD for one week (men) / More than 3 SD for one occasion or more than 7 SD for one week (women) or scores of 8 or more on Alcohol Use Disorders Identification Test (AUDIT) for men / scores of 6 of more on AUDIT for women
(b) Adult men and women aged 20 to 60 years

[Normal control group]
(a) Adult men and women aged 20 to 60 years
    Exclusion Criteria 
    Exclusion criteria
(a) Have major medical, neurological, or psychiatric illnesses
(b) Pregnant, lactation, or have a pregnancy plan
(c) Not compatible for MRI and PET-CT (internal metal and medical devices, claustrophobia, etc.)
(d) History of seizures
(e) Problems with stimulation electrodes due to deformity of the scalp, inflammation reaction or other dermatological problems
(f) History of cancer in the past three years
(g) Surgery for brain vessels such as brain surgery or carotid surgery
(h) Dyspnea when sitting still
(i) Loss of consciousness for more than one hour due to other causes other than general anesthesia
(j) Have been hospitalized for a head injury
    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 /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    Alcohol use disorder symptoms such as cravings assessed by self-report questionnaire
    Timepoint 
    Baseline, 1 month, 2 months
    Primary Outcome(s) 2
    Outcome 
    Maintenance of abstinence from alcohol
    Timepoint 
    Baseline, 1 month, 2 months
    Secondary Outcome(s) 1
    Outcome 
    Changes in structure, function, and metabolism of the brain evaluated using MRI and PET
    Timepoint 
    Baseline, 1 month, 2 months
    Secondary Outcome(s) 2
    Outcome 
    Changes in depressive symptoms assessed by self-report questionnaire
    Timepoint 
    Baseline, 1 month, 2 months
    Secondary Outcome(s) 3
    Outcome 
    Changes in anxiety symptoms assessed by self-report questionnaire
    Timepoint 
    Baseline, 1 month, 2 months
    Secondary Outcome(s) 4
    Outcome 
    Changes in cognitive function evaluated by neuropsychological tests
    Timepoint 
    Baseline, 1 month, 2 months

  • 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
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