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The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Depression Using Medical Imaging

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
antidepressants
Sponsored by
Health Science Center of Xi'an Jiaotong University
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(TMS), Resting-state functional MRI(fMRI)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

TMS treatment group and medication group:

  1. Hospitalized patients or outpatients which meet Clinical diagnosis of depression such as international Classification of diseases-10( ICD-10) which is the diagnostic criteria of unipolar depression;Scores of Hamilton Depression Scale (HAMD) ≥ 18 points, scores of clinical total impression scale (CGI)≥ 3 points, and without severe suicidal tendency;
  2. 18-60 years old, male or female;
  3. Physical and laboratory examination, electrocardiogram(ECG),and electroencephalogram (EEG) with no abnormal changes;
  4. No serious or unstable cerebrovascular, liver, kidney, endocrine, blood and other somatic diseases;
  5. The patient or the legal guardian should sign a written informed consent after fully understanding the research content of this study.

Healthy control group:

  1. 18-60 years old, male or female;
  2. Physical and laboratory examination, electrocardiogram(ECG),and electroencephalogram (EEG) with no abnormal changes;
  3. No serious or unstable heart, liver, kidney, endocrine, blood and other somatic diseases;
  4. Subjects or their legal guardians sign written informed consents after fully understanding the research contents of this study.

Exclusion Criteria:

  1. Mental disorders caused by organic diseases such as brain tumors;
  2. Serious somatic diseases, severe suicidal tendency and pacemakers;
  3. Secondary depressive disorder, psychotic depression or bipolar disorder caused by drugs;
  4. Antidepressants or psychoactive drugs were taken one month before enrollment.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

TMS treatment group

medication group

healthy control group

Arm Description

In the Transcranial magnetic stimulation (TMS) treatment group patients with severe depression receive rTMS treatment without drug treatment.

In the medication group patients with severe depression are treated with anti-depressants.

The control group don't accept intervention and treatment.

Outcomes

Primary Outcome Measures

Hamilton Depression Scale-17(HAMD-17)
HAMD-17 are to evaluate the severity degree of depression and the clinical effectiveness for treatment of depression.HAMD-17 scores range in 0-52 points.Total score which is between 7 and 16 means that volunteer may be with depression.Total score which is between 17 and 23 means that volunteer certainly is with depression.Total score which is more than 23 means that volunteer is with severe depression.
Multimodal Magnetic Resonance Imaging
Multimodal Magnetic Resonance Imaging include 3D-T1, ASL, DTI, resting-state functional MRI, etc.these show the Brain changes.

Secondary Outcome Measures

Clinical Global Impression.(CGI)
CGI is to evaluate the severity degree of depression to estimate whether patients are in accordance with inclusion criteria which concludes severty of illness (si),global improvement (gi) and efficacy index (ei).Si scores range in 0-7 points.Gi scores range in 0-7 points.Ei scores range in 0-4.00 points.
Wisconsin Card Sorting Test (WCST)
WCST is to to evaluate the cognitive function of volunteers.Total score which is less 69 means that volunteer suffers from mental deficiency.

Full Information

First Posted
February 7, 2018
Last Updated
April 8, 2018
Sponsor
Health Science Center of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03500029
Brief Title
The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Depression Using Medical Imaging
Official Title
The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Patients With Depression Using Multimodal Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Science Center of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depression is the most common psychiatric condition and a important public health concern in society. But medications for depression don't work as well as people expected and cause serious side-effects. Transcranial magnetic stimulation (TMS) is a noninvasive electrical stimulation treatment for depression, which has been approved by the FDA and added to the Guidelines for the Treatment of Depression in China. Despite the effect of the treatment is clear ,the TMS target,the neural circuit which plays a role in TMS and its mechanism remain unknown now. TBS target and effective site may be not in the same position. A large number of previous studies demonstrate the advantages and application prospects of different techniques of magnetic resonance (MR)in the study of pathogenesis of depression. Based on the results of previous research supported by the National Natural Science Foundation of China,the National Key Technology Research and Development Program of China during the "10th Five-Year Plan" and New Health Care and New technology. project team puts forward the idea of joint use of brain structure imaging of MR ,Diffusion Tensor Imaging (DTI) and resting-state functional MRI (fMRI) with different analysis methods to conduct a comprehensive study. The study is focused on the effects of TBS treatment on brain structure network, fiber connectivity network and functional connectivity network ,and nodes affected by it. Then we make further investigation about the mechanism of TMS treatment. The research will provide not only help for studying the pathogenesis of depression but also more reliable targets of next TMS treatment.
Detailed Description
The advantages of 3D T1 WI are thin slice scan，no interval, scanning fast and three-dimension reconstruction in any orientation compared with 2D SE. It is not easy to miss small lesions, and shows normal anatomy and lesions more objectively and more accurately. Doppler tissue imaging (DTI) can reflect white matter fiber so that can be used to determine whether the various diseases affect nerve cell connections. Arterial spin labeling (ASL) is non-drug perfusion imaging and completely noninvasive technology which can reflect brain perfusion better. Resting-state functional MRI (fMRI) is used to located the abnormal brain regions whose activity is consistent with dorsolateral prefrontal cortex (DLPFC) by the abnormal resting spontaneous brain activity in patients with depression and the abnormal functional connectivity network.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Transcranial magnetic stimulation(TMS), Resting-state functional MRI(fMRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS treatment group
Arm Type
Experimental
Arm Description
In the Transcranial magnetic stimulation (TMS) treatment group patients with severe depression receive rTMS treatment without drug treatment.
Arm Title
medication group
Arm Type
Active Comparator
Arm Description
In the medication group patients with severe depression are treated with anti-depressants.
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
The control group don't accept intervention and treatment.
Intervention Type
Radiation
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
TMS treatment group is treated with TMS for 20-40 minutes a time, 5 times a week. The stimulation parameters were 20 Hz and 80% MT. Each stimulation continues for 2 seconds, and the interval time of stimulation is 58 seconds.
Intervention Type
Drug
Intervention Name(s)
antidepressants
Intervention Description
Medication group is treated with anti-depression for 6 weeks. The drugs and their doses belong to the first-line treatment for depression in the current guideline .
Primary Outcome Measure Information:
Title
Hamilton Depression Scale-17(HAMD-17)
Description
HAMD-17 are to evaluate the severity degree of depression and the clinical effectiveness for treatment of depression.HAMD-17 scores range in 0-52 points.Total score which is between 7 and 16 means that volunteer may be with depression.Total score which is between 17 and 23 means that volunteer certainly is with depression.Total score which is more than 23 means that volunteer is with severe depression.
Time Frame
Difference at HAMD-17 between day 1，week 2 and week 4.
Title
Multimodal Magnetic Resonance Imaging
Description
Multimodal Magnetic Resonance Imaging include 3D-T1, ASL, DTI, resting-state functional MRI, etc.these show the Brain changes.
Time Frame
Difference at Multimodal Magnetic Resonance Imaging between day 1,week 2 and week 4.
Secondary Outcome Measure Information:
Title
Clinical Global Impression.(CGI)
Description
CGI is to evaluate the severity degree of depression to estimate whether patients are in accordance with inclusion criteria which concludes severty of illness (si),global improvement (gi) and efficacy index (ei).Si scores range in 0-7 points.Gi scores range in 0-7 points.Ei scores range in 0-4.00 points.
Time Frame
Difference at CGI between day 1，week 2 and week 4.
Title
Wisconsin Card Sorting Test (WCST)
Description
WCST is to to evaluate the cognitive function of volunteers.Total score which is less 69 means that volunteer suffers from mental deficiency.
Time Frame
Difference at WCST between day 1,week 2 and week 4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: TMS treatment group and medication group: Hospitalized patients or outpatients which meet Clinical diagnosis of depression such as international Classification of diseases-10( ICD-10) which is the diagnostic criteria of unipolar depression;Scores of Hamilton Depression Scale (HAMD) ≥ 18 points, scores of clinical total impression scale (CGI)≥ 3 points, and without severe suicidal tendency; 18-60 years old, male or female; Physical and laboratory examination, electrocardiogram(ECG),and electroencephalogram (EEG) with no abnormal changes; No serious or unstable cerebrovascular, liver, kidney, endocrine, blood and other somatic diseases; The patient or the legal guardian should sign a written informed consent after fully understanding the research content of this study. Healthy control group: 18-60 years old, male or female; Physical and laboratory examination, electrocardiogram(ECG),and electroencephalogram (EEG) with no abnormal changes; No serious or unstable heart, liver, kidney, endocrine, blood and other somatic diseases; Subjects or their legal guardians sign written informed consents after fully understanding the research contents of this study. Exclusion Criteria: Mental disorders caused by organic diseases such as brain tumors; Serious somatic diseases, severe suicidal tendency and pacemakers; Secondary depressive disorder, psychotic depression or bipolar disorder caused by drugs; Antidepressants or psychoactive drugs were taken one month before enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenwang Jin, doctorate
Phone
18991232597
Ext
14436421831
Email
Jin1115@mail.xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenwang Jin, doctorate
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiancang Ma, doctorate

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21511342
Citation
Bora E, Fornito A, Pantelis C, Yucel M. Gray matter abnormalities in Major Depressive Disorder: a meta-analysis of voxel based morphometry studies. J Affect Disord. 2012 Apr;138(1-2):9-18. doi: 10.1016/j.jad.2011.03.049. Epub 2011 Apr 20.
Results Reference
result
PubMed Identifier
24148027
Citation
Chase HW, Nusslock R, Almeida JR, Forbes EE, LaBarbara EJ, Phillips ML. Dissociable patterns of abnormal frontal cortical activation during anticipation of an uncertain reward or loss in bipolar versus major depression. Bipolar Disord. 2013 Dec;15(8):839-854. doi: 10.1111/bdi.12132. Epub 2013 Oct 21. Erratum In: Bipolar Disord. 2014 Mar;16(2):e2.
Results Reference
result
Links:
URL
https://doi.org/10.1016/j.jad.2014.06.037
Description
An fMRI study of emotional face processing in adolescent major depression
URL
https://doi.org/10.1016/j.neuroimage.2009.06.043
Description
A comparison between voxel-based cortical thickness and voxel-based morphometry in normal aging

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The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Depression Using Medical Imaging

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