Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Shanghai Mental Health Center

Status: Unknown

Conditions: Treatment Resistant Schizophrenia Based on the DTMS

Treatments: Device: High frequency deep transcranial magnetic stimulation with H1 coil; Device: deep transcranial magnetic stimulation with H1 coil; Device: iTBS deep transcranial magnetic stimulation with H1 coil

Study type: Interventional

Funder types: Other

Identifiers

NCT05167942

20y11906300

Details and patient eligibility

About

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

Full 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.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 3 patient groups

Sham dTMS

Sham Comparator group

Description:

29 patients will be randomly allocated into this group,they will receive sham stimulation.

Treatment:

Device: deep transcranial magnetic stimulation with H1 coil

dTMS 20Hz

Active Comparator group

Description:

29 patients will be randomly allocated into this group,they will receive real stimulation.

Treatment:

Device: High frequency deep transcranial magnetic stimulation with H1 coil

dTMS iTBS

Active Comparator group

Description:

29 patients will be randomly allocated into this group,they will receive real stimulation.

Treatment:

Device: iTBS deep transcranial magnetic stimulation with H1 coil