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Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

Primary Purpose

Depression, Treatment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TBS
Sham
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, transcranial magnetic stimulation, theta-burst stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The diagnostic criteria of DSM-IV for MDD
  • The range of the age from 18 to 70-year-old
  • Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
  • Competent for a full explanation of the study and written informed consent is obtained.

Exclusion Criteria:

  • Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
  • Pregnant
  • History or family history of seizure disorder
  • Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
  • Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Theta-burst stimulation (TBS)

    Sham controlled intervention

    Arm Description

    Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)

    The sham-TBS coil produced a similar sound without a magnetic pulse.

    Outcomes

    Primary Outcome Measures

    Hamilton Rating Scale for Depression (HAMD)
    The Hamilton Depression scale sum score (HAMD21) Not depressed: 0-7 Mild: 8-13 Moderate: 14-18 Severe: 19-22 Very severe: >23

    Secondary Outcome Measures

    Response rate
    The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.
    Remission rate
    The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    October 7, 2022
    Sponsor
    National Science Council, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04364880
    Brief Title
    Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
    Official Title
    Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    December 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
    Detailed Description
    This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Treatment
    Keywords
    depression, transcranial magnetic stimulation, theta-burst stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Theta-burst stimulation (TBS)
    Arm Type
    Experimental
    Arm Description
    Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
    Arm Title
    Sham controlled intervention
    Arm Type
    Sham Comparator
    Arm Description
    The sham-TBS coil produced a similar sound without a magnetic pulse.
    Intervention Type
    Device
    Intervention Name(s)
    TBS
    Intervention Description
    Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
    Intervention Type
    Device
    Intervention Name(s)
    Sham
    Intervention Description
    The sham-TBS coil produced a similar sound without a magnetic pulse.
    Primary Outcome Measure Information:
    Title
    Hamilton Rating Scale for Depression (HAMD)
    Description
    The Hamilton Depression scale sum score (HAMD21) Not depressed: 0-7 Mild: 8-13 Moderate: 14-18 Severe: 19-22 Very severe: >23
    Time Frame
    From Weeks 0 to 24
    Secondary Outcome Measure Information:
    Title
    Response rate
    Description
    The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group.
    Time Frame
    From Weeks 0 to 24
    Title
    Remission rate
    Description
    The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission.
    Time Frame
    From Weeks 0 to 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The diagnostic criteria of DSM-IV for MDD The range of the age from 18 to 70-year-old Physically healthy on medical history, physical examination, and laboratory parameters within normal limits Competent for a full explanation of the study and written informed consent is obtained. Exclusion Criteria: Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded Pregnant History or family history of seizure disorder Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kuan-Pin Su, MD PhD
    Organizational Affiliation
    China Medical University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

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