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

September 23, 2021 updated by: Shanghai Mental Health Center

Modulation of rTMS on Hippocampal Neurogenesis and Functional Network in Early Schizophrenia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SHAM_COMPARATOR: rTMS targeting the right DLPFC
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.
Device: repetitive transcranial magnetic stimulation(DLPFC)
high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days.
SHAM_COMPARATOR: rTMS targeting the left LPC
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.
Device: repetitive transcranial magnetic stimulation(LPC)
high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days
NO_INTERVENTION: Observation group
To investigate the abnormalities of hippocampal neurogenesis in patients with early schizophrenia(n=30) compared to healthy controls(n=30)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in MATRICS Consensus Cognitive Battery
Time Frame: baseline,24 hours after the rTMS treatment,30 days
MATRICS Consensus Cognitive Battery
baseline,24 hours after the rTMS treatment,30 days
Change of hippocampal neurogenesis(from baseline)
Time Frame: baseline,24 hours after the rTMS treatment
Quantify neural stem cells in hippocampal by using H1-MRS
baseline,24 hours after the rTMS treatment
Change of cortical-hippocampal functional network(from baseline)
Time Frame: baseline,24 hours after the rTMS treatment
Resting-state fMRI data are acquired
baseline,24 hours after the rTMS treatment
Change from baseline in associative memory
Time Frame: baseline,24 hours after the rTMS treatment,30 days
associative memory
baseline,24 hours after the rTMS treatment,30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Time Frame: baseline,24 hours after the rTMS treatment,30 days
Positive and Negative Syndrome Scale(PANSS)
baseline,24 hours after the rTMS treatment,30 days
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Time Frame: baseline,24 hours after the rTMS treatment,30 days
Scale for the Assessment of Negative Symptoms
baseline,24 hours after the rTMS treatment,30 days
Change from baseline in UCSD Performance-based Skills Assessment-Brief(UPSA-B)
Time Frame: baseline,24 hours after the rTMS treatment,30 days
UCSD Performance-based Skills Assessment-Brief
baseline,24 hours after the rTMS treatment,30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YG2017ZD13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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