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Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Primary Purpose

Treatment Resistant Schizophrenia Based on the DTMS

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
deep transcranial magnetic stimulation with H1 coil
High frequency deep transcranial magnetic stimulation with H1 coil
iTBS deep transcranial magnetic stimulation with H1 coil
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Schizophrenia Based on the DTMS focused on measuring Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham dTMS

dTMS 20Hz

dTMS iTBS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
Change from baseline in MATRICS Consensus Cognitive Battery
MATRICS Consensus Cognitive Battery

Secondary Outcome Measures

Change of PFC neurogenesis
Quantify neural stem cells in hippocampal by using H1-MRS

Full Information

First Posted
December 10, 2021
Last Updated
December 10, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05167942
Brief Title
Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
Official Title
Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Schizophrenia Based on the DTMS
Keywords
Deep Transcranial Magnetic Stimulation, Treatment Resistant Schizophrenia, H1 coil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham dTMS
Arm Type
Sham Comparator
Arm Description
29 patients will be randomly allocated into this group,they will receive sham stimulation.
Arm Title
dTMS 20Hz
Arm Type
Active Comparator
Arm Description
29 patients will be randomly allocated into this group,they will receive real stimulation.
Arm Title
dTMS iTBS
Arm Type
Active Comparator
Arm Description
29 patients will be randomly allocated into this group,they will receive real stimulation.
Intervention Type
Device
Intervention Name(s)
deep transcranial magnetic stimulation with H1 coil
Intervention Description
Sham deep transcranial magnetic stimulation on PFC .Duration:40 days.
Intervention Type
Device
Intervention Name(s)
High frequency deep transcranial magnetic stimulation with H1 coil
Intervention Description
high frequency(20Hz) deep transcranial magnetic stimulation on PFC .Duration:40 days.
Intervention Type
Device
Intervention Name(s)
iTBS deep transcranial magnetic stimulation with H1 coil
Intervention Description
iTBS deep transcranial magnetic stimulation on PFC .Duration:40 days.
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Description
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
Time Frame
baseline,24 hours after the dTMS treatment,40 days
Title
Change from baseline in MATRICS Consensus Cognitive Battery
Description
MATRICS Consensus Cognitive Battery
Time Frame
baseline,24 hours after the rTMS treatment,40 days
Secondary Outcome Measure Information:
Title
Change of PFC neurogenesis
Description
Quantify neural stem cells in hippocampal by using H1-MRS
Time Frame
baseline,24 hours after the dTMS treatment,40days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang Liu, M.D.
Phone
8618017311138
Email
erliu110@126.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

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