Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-05

Study Completion Date

2022-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this research,we combine a cross-sectional case control study and a randomized controlled study.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sham stimulation

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

Group Type SHAM_COMPARATOR

deep transcranial magnetic stimulation with H7 coil

Intervention Type DEVICE

low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

real stimulation dTMS targeting the ACC

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

Group Type ACTIVE_COMPARATOR

deep transcranial magnetic stimulation with H7 coil

Intervention Type DEVICE

low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

Interventions

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deep transcranial magnetic stimulation with H7 coil

low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.

Intervention Type DEVICE

Eligibility Criteria

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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%)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No