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Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Primary Purpose

Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
deep transcranial magnetic stimulation with H7 coil
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia focused on measuring Treatment Resistance Schizophrenia, Deep Transcranial Magnetic Stimulation, anterior cingulate cortex, glutamate, H7 coil

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

sham stimulation

real stimulation dTMS targeting the ACC

Arm Description

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

20 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 30 days
Change from baseline in MATRICS Consensus Cognitive Battery
MATRICS Consensus Cognitive Battery

Secondary Outcome Measures

Change of ACC neurogenesis
Quantify neural stem cells in hippocampal by using H1-MRS
Change in glutamate level

Full Information

First Posted
July 16, 2020
Last Updated
September 12, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04478032
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 30, 2022 (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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this research,we combine a cross-sectional case control study and a randomized controlled study.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
20 patients will be randomly allocated into this group,they will receive sham stimulation.
Arm Title
real stimulation dTMS targeting the ACC
Arm Type
Active Comparator
Arm Description
20 patients will be randomly allocated into this group,they will receive real stimulation.
Intervention Type
Device
Intervention Name(s)
deep transcranial magnetic stimulation with H7 coil
Intervention Description
low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 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 30 days
Time Frame
baseline,24 hours after the dTMS treatment,30 days
Title
Change from baseline in MATRICS Consensus Cognitive Battery
Description
MATRICS Consensus Cognitive Battery
Time Frame
baseline,24 hours after the rTMS treatment,30 days
Secondary Outcome Measure Information:
Title
Change of ACC neurogenesis
Description
Quantify neural stem cells in hippocampal by using H1-MRS
Time Frame
baseline,24 hours after the dTMS treatment
Title
Change in glutamate level
Time Frame
baseline,24 hours after the dTMS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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%)
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
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengtang LIU
Phone
8618017311138
Email
erliu110@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia

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