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
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, transcranial magnetic stimulation, theta-burst stimulation
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)
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
NCT ID
NCT04364880
First Posted
April 23, 2020
Last Updated
October 7, 2022
Sponsor
National Science Council, Taiwan
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
Learn more about this trial
Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression
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