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

NCT03500029 | Unknown Phase 1 DMC

• 1 other identifier: JIN1115
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Transcranial magnetic stimulation(TMS); Resting-state functional MRI(fMRI)

Outcome Measures

Primary Outcomes (2)

• 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.

  Difference at HAMD-17 between day 1，week 2 and week 4.

• Multimodal Magnetic Resonance Imaging

  Multimodal Magnetic Resonance Imaging include 3D-T1, ASL, DTI, resting-state functional MRI, etc.these show the Brain changes.

  Difference at Multimodal Magnetic Resonance Imaging between day 1,week 2 and week 4.

Secondary Outcomes (2)

• Clinical Global Impression.(CGI)

  Difference at CGI between day 1，week 2 and week 4.

• Wisconsin Card Sorting Test (WCST)

  Difference at WCST between day 1,week 2 and week 4.

Study Arms (3)

TMS treatment group

EXPERIMENTAL

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

Radiation: Transcranial magnetic stimulation (TMS)

medication group

ACTIVE COMPARATOR

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

Drug: antidepressants

healthy control group

NO INTERVENTION

The control group don't accept intervention and treatment.

Interventions

Transcranial magnetic stimulation (TMS) 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.

TMS treatment group

antidepressants 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 .

medication group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 21511342 RESULT

• 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.

  PMID: 24148027 RESULT

Related Links

• An fMRI study of emotional face processing in adolescent major depression
• A comparison between voxel-based cortical thickness and voxel-based morphometry in normal aging

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation; Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Chenwang Jin, doctorate

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Chenwang Jin, doctorate

CONTACT

18991232597; Jin1115@mail.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: April 17, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: February 1, 2022
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CN (1)