Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Study Overview
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Brief Summary
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Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC

Detailed Description
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This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal dTMS treatment pattern on cognitive function.

Official Title
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Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Conditions
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Treatment Resistant Schizophrenia Based on the DTMS

Intervention / Treatment
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* Device: deep transcranial magnetic stimulation with H1 coil
* Device: High frequency deep transcranial magnetic stimulation with H1 coil
* Device: iTBS deep transcranial magnetic stimulation with H1 coil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with schizophrenia who meet the dsm-5 diagnostic criteria Aged from 18 to 55 Right-handedness, normal hearing, visual acuity or corrected visual acuity Written informed consent of the patient and his/her family All patients received MINI 7.0 structured interviews Exclusion Criteria: Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate Medically unstable for at least 1 month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham dTMS<br>29 patients will be randomly allocated into this group,they will receive sham stimulation. | Device: deep transcranial magnetic stimulation with H1 coil<br>* Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.<br>|
| Active Comparator: dTMS 20Hz<br>29 patients will be randomly allocated into this group,they will receive real stimulation. | Device: High frequency deep transcranial magnetic stimulation with H1 coil<br>* high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.<br>|
| Active Comparator: dTMS iTBS<br>29 patients will be randomly allocated into this group,they will receive real stimulation. | Device: iTBS deep transcranial magnetic stimulation with H1 coil<br>* iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale(PANSS) | Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days | baseline,24 hours after the dTMS treatment,40 days | 
| Change from baseline in MATRICS Consensus Cognitive Battery | MATRICS Consensus Cognitive Battery | baseline,24 hours after the rTMS treatment,40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of PFC neurogenesis | Quantify neural stem cells in hippocampal by using H1-MRS | baseline,24 hours after the dTMS treatment,40days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil