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Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

NCT ID: NCT05167942

Last Updated: 2021-12-22

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Treatment Resistant Schizophrenia Based on the DTMS

Keywords

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Deep Transcranial Magnetic Stimulation Treatment Resistant Schizophrenia H1 coil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham dTMS

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

Group Type SHAM_COMPARATOR

deep transcranial magnetic stimulation with H1 coil

Intervention Type DEVICE

Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.

dTMS 20Hz

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

Group Type ACTIVE_COMPARATOR

High frequency deep transcranial magnetic stimulation with H1 coil

Intervention Type DEVICE

high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.

dTMS iTBS

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

Group Type ACTIVE_COMPARATOR

iTBS deep transcranial magnetic stimulation with H1 coil

Intervention Type DEVICE

iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.

Interventions

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deep transcranial magnetic stimulation with H1 coil

Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.

Intervention Type DEVICE

High frequency deep transcranial magnetic stimulation with H1 coil

high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.

Intervention Type DEVICE

iTBS deep transcranial magnetic stimulation with H1 coil

iTBS deep transcranial magnetic stimulation on PFC .Duration:40 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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dengtang Liu, M.D.

Role: CONTACT

Phone: 8618017311138

Email: [email protected]

Other Identifiers

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20y11906300

Identifier Type: -

Identifier Source: org_study_id