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Modulation of Repetitive Transcranial Magnetic Stimulation on Hippocampal Neurogenesis and Functional Network in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation(DLPFC)
repetitive transcranial magnetic stimulation(LPC)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring first episode schizophrenia, rTMS, hippocampal neurogenesis, MRS, cognitive function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers
  • Early schizophrenia group:

Inclusion Criteria:

  1. The Structured Interview for Prodromal Symptoms (SIPS) was employed.
  2. Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis.
  3. 18-50years of age,right-handed,normal vision or corrected vision, Han nationality.
  4. Disease course less than 5 years.
  5. Written informed consent

Observation group: First-episode, In addition to criteria1-3,5,antipsychotics naïve,or antipsychotics withdrawal for more than 3 months.

Intervention group:In addition to criteria 1-6,currently under medication and medically stable for at least 1 month(PANSS score fluctuation<10%);continue the original antipsychotics for at least 1 months after recruitment,with consent of the patients,their psychiatrists and family members.

Exclusion criteria:

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%)

  • Healthy controls:

Inclusion Criteria:

  1. The Structured Interview for Prodromal Symptoms (SIPS) was employed
  2. Matched to the early schizophrenia group in terms of age,sex ratio,handedness,and estimated premorbid IQ
  3. normal vision or corrected vision, Han nationality
  4. Written informed consent

Exclusion Criteria:

History of psychiatric disease in the subjects themselves or a family history of mental disorder in their first-degree relatives,neurological illness,severe physical illness,substance abuse or alcohol dependence,mental retardation.

Sites / Locations

  • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Sham Comparator

No Intervention

Arm Label

rTMS targeting the right DLPFC

rTMS targeting the left LPC

Observation group

Arm Description

60 patients will be randomly allocated into this group,half of them will receive iTBS on the right DLPFC,while the other half will receive sham stimulation.

60 patients will be randomly allocated into this group,half of them will receive iTBS on left LPC,while the other half will receive sham stimulation.

To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30)

Outcomes

Primary Outcome Measures

Change from baseline in MATRICS Consensus Cognitive Battery
MATRICS Consensus Cognitive Battery
Change of hippocampal neurogenesis(from baseline)
Quantify neural stem cells in hippocampal by using H1-MRS
Change of cortical-hippocampal functional network(from baseline)
Resting-state fMRI data are acquired
Change from baseline in associative memory
associative memory

Secondary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Positive and Negative Syndrome Scale(PANSS)
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Scale for the Assessment of Negative Symptoms
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)
UCSD Performance-based Skills Assessment-Brief

Full Information

First Posted
July 9, 2018
Last Updated
September 23, 2021
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03608462
Brief Title
Modulation of Repetitive Transcranial Magnetic Stimulation on Hippocampal Neurogenesis and Functional Network in Patients With Schizophrenia
Official Title
Modulation of rTMS on Hippocampal Neurogenesis and Functional Network in Early Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Jiao Tong University School of Medicine

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 high-frequency repetitive transcranial magnetic stimulation(rTMS) on the right dorsolateral prefrontal cortex(DLPFC) and left parietal cortex(LPC) could normalise cognitive abnormalities by promoting hippocampal neurogenesis and cortical-hippocampal function in patients with 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 intermittent theta burst stimulation (iTBS) on cognitive impairment in SZ patients with memory defects,as well as to elucidate the correlation between treatment effects and hippocampal neuroplasticity.
Detailed Description
This study includes 150 schizophrenia patients and 30 healthy controls.This study will investigate 1).abnormalities of hippocampal neurogenesis in patients with schizophrenia compared to healthy controls by using 1H-MRS technique 2a).potential modulation effects of repetitive transcranial magnetic stimulation(rTMS) on hippocampal neurogenesis and cortical-hippocampal function of patients with schizophrenia 2b).the optimal rTMS therapy pattern on promoting hippocampal neurogenesis and improving cortico-hippocampal function by comparing the outcome of stimulating two regions(right dorsolateral prefrontal cortex or left parietal cortex) respectively 3).the therapeutic efficacy of rTMS 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 rTMS treatment pattern on cognitive function by comparing the outcome of stimulating two regions(DLPFC or LPC) respectively 4)association between therapeutic efficacy of rTMS on cognitive deficits and rTMS modulation on hippocampal neurogenesis and its network function,in order to elucidate the underlying mechanism of therapeutic effects of rTMS on cognitive dysfunction in schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
first episode schizophrenia, rTMS, hippocampal neurogenesis, MRS, cognitive function

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
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS targeting the right DLPFC
Arm Type
Sham Comparator
Arm Description
60 patients will be randomly allocated into this group,half of them will receive iTBS on the right DLPFC,while the other half will receive sham stimulation.
Arm Title
rTMS targeting the left LPC
Arm Type
Sham Comparator
Arm Description
60 patients will be randomly allocated into this group,half of them will receive iTBS on left LPC,while the other half will receive sham stimulation.
Arm Title
Observation group
Arm Type
No Intervention
Arm Description
To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30)
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation(DLPFC)
Intervention Description
high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation(LPC)
Intervention Description
high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days
Primary Outcome Measure Information:
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
Title
Change of hippocampal neurogenesis(from baseline)
Description
Quantify neural stem cells in hippocampal by using H1-MRS
Time Frame
baseline,24 hours after the rTMS treatment
Title
Change of cortical-hippocampal functional network(from baseline)
Description
Resting-state fMRI data are acquired
Time Frame
baseline,24 hours after the rTMS treatment
Title
Change from baseline in associative memory
Description
associative memory
Time Frame
baseline,24 hours after the rTMS treatment,30 days
Secondary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Description
Positive and Negative Syndrome Scale(PANSS)
Time Frame
baseline,24 hours after the rTMS treatment,30 days
Title
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Description
Scale for the Assessment of Negative Symptoms
Time Frame
baseline,24 hours after the rTMS treatment,30 days
Title
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)
Description
UCSD Performance-based Skills Assessment-Brief
Time Frame
baseline,24 hours after the rTMS treatment,30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Early schizophrenia group: Inclusion Criteria: The Structured Interview for Prodromal Symptoms (SIPS) was employed. Meet the diagnostic criteria of Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V) schizophrenia or schizophreniform psychosis. 18-50years of age,right-handed,normal vision or corrected vision, Han nationality. Disease course less than 5 years. Written informed consent Observation group: First-episode, In addition to criteria1-3,5,antipsychotics naïve,or antipsychotics withdrawal for more than 3 months. Intervention group:In addition to criteria 1-6,currently under medication and medically stable for at least 1 month(PANSS score fluctuation<10%);continue the original antipsychotics for at least 1 months after recruitment,with consent of the patients,their psychiatrists and family members. Exclusion criteria: 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%) Healthy controls: Inclusion Criteria: The Structured Interview for Prodromal Symptoms (SIPS) was employed Matched to the early schizophrenia group in terms of age,sex ratio,handedness,and estimated premorbid IQ normal vision or corrected vision, Han nationality Written informed consent Exclusion Criteria: History of psychiatric disease in the subjects themselves or a family history of mental disorder in their first-degree relatives,neurological illness,severe physical illness,substance abuse or alcohol dependence,mental retardation.
Facility Information:
Facility Name
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Modulation of Repetitive Transcranial Magnetic Stimulation on Hippocampal Neurogenesis and Functional Network in Patients With Schizophrenia

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