Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
- Conditions
- Treatment Resistant Schizophrenia Based on the DTMS
- Interventions
- Device: High frequency deep transcranial magnetic stimulation with H1 coilDevice: deep transcranial magnetic stimulation with H1 coilDevice: iTBS deep transcranial magnetic stimulation with H1 coil
- Registration Number
- NCT05167942
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 87
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dTMS 20Hz High frequency deep transcranial magnetic stimulation with H1 coil 29 patients will be randomly allocated into this group,they will receive real stimulation. Sham dTMS deep transcranial magnetic stimulation with H1 coil 29 patients will be randomly allocated into this group,they will receive sham stimulation. dTMS iTBS iTBS deep transcranial magnetic stimulation with H1 coil 29 patients will be randomly allocated into this group,they will receive real stimulation.
- Primary Outcome Measures
Name Time Method Change from baseline in MATRICS Consensus Cognitive Battery baseline,24 hours after the rTMS treatment,40 days MATRICS Consensus Cognitive Battery
Change from baseline in Positive and Negative Syndrome Scale(PANSS) baseline,24 hours after the dTMS treatment,40 days Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
- Secondary Outcome Measures
Name Time Method Change of PFC neurogenesis baseline,24 hours after the dTMS treatment,40days Quantify neural stem cells in hippocampal by using H1-MRS
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, China