Clinical trial NCT04478032: Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia
Official title: Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia: a Double-Blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia
Keywords: Treatment Resistance Schizophrenia
Deep Transcranial Magnetic Stimulation
anterior cingulate cortex
glutamate
H7 coil
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this research,we combine a cross-sectional case control study and a randomized controlled study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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%)

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale(PANSS)
timeFrame: baseline,24 hours after the dTMS treatment,30 days
measure: Change from baseline in MATRICS Consensus Cognitive Battery
timeFrame: baseline,24 hours after the rTMS treatment,30 days
Secondary outcomes:
measure: Change of ACC neurogenesis
timeFrame: baseline,24 hours after the dTMS treatment
measure: Change in glutamate level
timeFrame: baseline,24 hours after the dTMS treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: