Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Change from baseline in MATRICS Consensus Cognitive Battery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sham dTMS
29 patients will be randomly allocated into this group,they will receive sham stimulation.
Intervention: deep transcranial magnetic stimulation with H1 coil (Device)
dTMS 20Hz
29 patients will be randomly allocated into this group,they will receive real stimulation.
Intervention: High frequency deep transcranial magnetic stimulation with H1 coil (Device)
dTMS iTBS
29 patients will be randomly allocated into this group,they will receive real stimulation.
Intervention: iTBS deep transcranial magnetic stimulation with H1 coil (Device)
Outcomes
Primary Outcomes
Change from baseline in MATRICS Consensus Cognitive Battery
Time Frame: baseline,24 hours after the rTMS treatment,40 days
MATRICS Consensus Cognitive Battery
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Time Frame: 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 Outcomes
- Change of PFC neurogenesis(baseline,24 hours after the dTMS treatment,40days)