The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Depression Using Medical Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03500029|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Radiation: Transcranial magnetic stimulation (TMS) Drug: antidepressants||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Study About Mechanism of Transcranial Magnetic Stimulation Treatment of Patients With Depression Using Multimodal Magnetic Resonance Imaging|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: TMS treatment group
In the Transcranial magnetic stimulation (TMS) treatment group patients with severe depression receive rTMS treatment without drug treatment.
Radiation: 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.
Active Comparator: medication group
In the medication group patients with severe depression are treated with anti-depressants.
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 .
No Intervention: healthy control group
The control group don't accept intervention and treatment.
- Hamilton Depression Scale-17(HAMD-17) [ Time Frame: Difference at HAMD-17 between day 1，week 2 and week 4. ]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 [ Time Frame: Difference at Multimodal Magnetic Resonance Imaging between day 1,week 2 and week 4. ]Multimodal Magnetic Resonance Imaging include 3D-T1, ASL, DTI, resting-state functional MRI, etc.these show the Brain changes.
- Clinical Global Impression.(CGI) [ Time Frame: Difference at CGI between day 1，week 2 and week 4. ]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) [ Time Frame: Difference at WCST between day 1,week 2 and week 4. ]WCST is to to evaluate the cognitive function of volunteers.Total score which is less 69 means that volunteer suffers from mental deficiency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500029
|Contact: Chenwang Jin, doctorate||18991232597 ext 14436421831||Jin1115@mail.xjtu.edu.cn|
|First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Xiancang Ma, doctorate|
|Study Chair:||Chenwang Jin, doctorate||First Affiliated Hospital Xi'an Jiaotong University|