Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Not Applicable

• Conditions: Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia
• Interventions: Device: deep transcranial magnetic stimulation with H7 coil

• Registration Number: NCT04478032
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Based on the hypothesis that low-frequency deep transcranial magnetic stimulation(dTMS) on anterior cingulate cortex （ACC） could down-regulate the glutamate level of ACC and regulate the acc-related 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 low-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of ACC

Detailed Description

This study includes 20 treatment resistance schizophrenia patients and 20 healthy controls.This study will investigate 1)abnormalities of the glutamate level of ACC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on anterior cingulate 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 Timeline

• Study Start: 2020-07-05
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-14
• Primary Completion: 2022-12
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with schizophrenia who meet the dsm-5 diagnostic criteria
• Aged from 18 to 60
• After 4 weeks of treatment with a sufficient dose of an antipsychotic (equivalent dose of 400 ~ 600 mg/ day chlorpromazine (CPZ)), no clinical improvement was achieved (at least two items in PANSS scale P1,P2,P3,N1,N4,N6,G5 and G9 ≥4 points, or cgi-s ≥4 points)
• Right-handedness, normal hearing, visual acuity or corrected visual acuity
• Written informed consent of the patient and his/her family

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
• A history of MECT within 6 months,or those with contraindications to MRI,rTMS
• Medically unstable for at least 1 month (PANSS score fluctuation>10%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham stimulation	deep transcranial magnetic stimulation with H7 coil	20 patients will be randomly allocated into this group,they will receive sham stimulation.
real stimulation dTMS targeting the ACC	deep transcranial magnetic stimulation with H7 coil	20 patients will be randomly allocated into this group,they will receive real stimulation.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale(PANSS)	baseline,24 hours after the dTMS treatment,30 days	Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 30 days
Change from baseline in MATRICS Consensus Cognitive Battery	baseline,24 hours after the rTMS treatment,30 days	MATRICS Consensus Cognitive Battery

Secondary Outcome Measures

Name	Time	Method
Change in glutamate level	baseline,24 hours after the dTMS treatment
Change of ACC neurogenesis	baseline,24 hours after the dTMS treatment	Quantify neural stem cells in hippocampal by using H1-MRS

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China