nTMS for Negative Symptom in Schizophrenia

December 1, 2025 updated by: Renrong Wu, Central South University

Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial

This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) of left Supramarginal Gyrus for negative symptoms. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. Treatment will last for 10 days, and data will be collected at baseline, 1 day and 1 month after treatment.

Study Overview

Status

Status

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

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 research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) for negative symptoms in patients with schizophrenia. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. By using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus, and parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.Both group will receive nTMS 5 times a day, total treatment for 10 days. Measurements included a pretreatment measurement session, 10 days of nTMS treatment, a post-treatment measurement, and a follow-up measurement 1 month after treatment. At baseline, data of demographic variables (such as sex, age, years of education, occupational status, social support) and disease characteristics (such as duration of illness, antipsychotic daily dose in chlorpromazine equivalents, family psychiatric history) will be collected.At baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7) , data of outcomes (such as Positive and Negative Symptom Scale (PANSS) score,Negative Symptoms(SANS) score and other secondary outcomes) will be collected in order to test the effectiveness of nTMS. After completing the 1 month follow-up, patients may choose whether to continue follow-up , in order to observe the long-term effects of the treatment. However, they will not receive any further experimental interventions.

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 (Estimated)

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.
40

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Mental Health Institute of Second Xiangya Hospital,CSU
        • Contact:

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1.Clinical diagnosis of schizophrenia according to ICD-11.
  • 2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).
  • 3.Score more than 4 points on either item of negative symptoms (N1-N7).
  • 4.Aged less than 60 years.

Exclusion Criteria:

  • 1.Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
  • 2.Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, etc.
  • 3.Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.
  • 4.Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
  • 5.Severe risk of self-injury or suicide
  • 6.Other conditions where the researchers find unsuitable for the treatment

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 Assignment
  • Masking: Quadruple

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.
Experimental: experimental group: active iTBS
Patients assigned to experimental group would receive treatment of active iTBS. 50 iTBS sessions (1,800 pulses per session, 50-minute intersession interval) were delivered 10 days at 90% resting motor threshold.
Device: Intermittent theta burst stimulation(iTBS)
By using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus.iTBS will be performed using Magstim Rapid² stimulator, parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.
Other Names:
  • Navigated transcranial magnetic stimulation (nTMS)
Sham Comparator: control group: sham iTBS
Patients assigned to control group would receive treatment of sham iTBS. The iTBS mode in sham iTBS is as the same as the active iTBS, but would be delivered with the sham coil, which provides the sensation of TBS without enough magnetic energy to reach the cortex.
Device: Sham stimulation
Patients in sham group would receive the same intervention procedure as the active ITBS group, but the coil will be replaced with sham coil, which provides the sensation of TBS without enough magnetic energy to reach the cortex.

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 in Scale for Assessment of Negative Symptoms(SANS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The SANS measures the severity of negative symptoms in schizophrenia. It contains 24 items, each item is scored from 0 to 5, higher score indicates more severe symptom. The SANS evaluates five dimensions of the negative symptoms, which are apathy, poverty of thought, abulia, social withdrawal and disorders of attention.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in Positive and Negative Symptom Scale (PANSS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The PANSS measures positive symptoms, negative symptoms and general psychopathology. It contains 30 items, each item is scored from 1 to 7, higher score indicates more severe psychopathology in the dimension. Here the investigators use the Chinese version of the PANSS to evaluate the severity of symptoms in schizophrenia in different participant and different treatment phase. The investigators mainly focus on change in the total score of the negative symptoms.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)

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
The data of head resting-state functional magnetic resonance imaging
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
All patients undergo head MRI scans in Siemens Trio 3.0T scanner. Resting functional MRI will be acquired based on Blood Oxygenation Level Dependent (BOLD) contrast. It can detect changes in blood oxygenation to analyze the change of brain function after intervention.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in MATRICS Consensus Cognitive Battery (MCCB) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The MCCB measures the cognitive function in schizophrenia and other neuropsychiatric diseases. It covers nine cognitive domains including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function and fine motor. Raw scores are converted to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. The changes of scores at different follow up timepoint will be used for assessing the improvement of cognitive function (higher score means a better outcome).
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in Personal and Social Performance Scale (PSP) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The PSP is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders : (a) socially useful activities, including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. Higher score indicates better social function.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in Global Assessment Function (GAF) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The GAF is a 100-point single-item rating scale that evaluate level of patients with schizophrenia, combining the level of social function and the severity of psychiatric symptoms to produce a single score. Higher score indicates better social function.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change of electroencephalogram
Time Frame: Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Neuroscan multi-channel evoked potential workstation records EEG data, using the international 10-20 system for electrode placement, with Ag/AgCl electrodes on a 64/128 electrode cap.
Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change of TMS-EEG (Transcranial Magnetic Stimulation Electroencephal
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Neuroscan multi-channel evoked potential workstation records EEG data, using the international 10-20 system for electrode placement, with Ag/AgCl electrodes on a 64/128 electrode cap. During TMS-EEG recording, stimulation of 100 single TMS pulses were delivered at 100% RMT intensity while participants remained at rest with their eyes open.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
MADRS is a 10-item scale that measures the severity of depression symptoms. Each item is scored from 0 to 6, higher score indicates more severe symptom.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Change in Calgary Depression Scale for Schizophrenia (CDSS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
CDSS is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia. Each item is scored from 0 to 3, higher score indicates more severe symptom.
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)

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.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Renrong Wu, M.D., Ph.D., Mental Health Institute of Second Xiangya Hospital,CSU

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.
November 22, 2024

Primary Completion (Estimated)

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.
February 1, 2026

Study Completion (Estimated)

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.
March 1, 2026

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).
October 9, 2024

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.
October 11, 2024

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.
October 15, 2024

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.
December 5, 2025

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.
December 1, 2025

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.
December 1, 2025

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.
  • nTMS

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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