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

NCT ID: NCT03500029

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-02-28

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TMS treatment group

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

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation (TMS)

Intervention Type: RADIATION

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.

medication group

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

Group Type: ACTIVE_COMPARATOR

antidepressants

Intervention Type: DRUG

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 .

healthy control group

The control group don't accept intervention and treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcranial magnetic stimulation (TMS)

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: RADIATION

antidepressants

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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Chenwang Jin

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chenwang Jin, doctorate

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chenwang Jin, doctorate

Role: CONTACT

Jin1115@mail.xjtu.edu.cn

18991232597 ext. 14436421831

Facility Contacts

Xiancang Ma, doctorate

Role: primary

References

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.

Reference Type: RESULT

PMID: 21511342 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24148027 (View on PubMed)

Related Links

https://doi.org/10.1016/j.jad.2014.06.037

An fMRI study of emotional face processing in adolescent major depression

https://doi.org/10.1016/j.neuroimage.2009.06.043

A comparison between voxel-based cortical thickness and voxel-based morphometry in normal aging

Other Identifiers

JIN1115

Identifier Type: -

Identifier Source: org_study_id