Clinical trial NCT05167942: Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
Official title: Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Resistant Schizophrenia Based on the DTMS
Keywords: Deep Transcranial Magnetic Stimulation
Treatment Resistant Schizophrenia
H1 coil
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale(PANSS)
timeFrame: baseline,24 hours after the dTMS treatment,40 days
measure: Change from baseline in MATRICS Consensus Cognitive Battery
timeFrame: baseline,24 hours after the rTMS treatment,40 days
Secondary outcomes:
measure: Change of PFC neurogenesis
timeFrame: baseline,24 hours after the dTMS treatment,40days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: