nTMS for Negative Symptom in Schizophrenia

NCT ID: NCT06642675

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent theta burst stimulation(iTBS)

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Navigated transcranial magnetic stimulation (nTMS)

Eligibility Criteria

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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
Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Renrong Wu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renrong Wu, M.D., Ph.D.

Role: STUDY_CHAIR

Mental Health Institute of Second Xiangya Hospital,CSU

Locations

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Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Renrong Wu, M.D., Ph.D.

Role: CONTACT

15874179855

Facility Contacts

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Renrong Wu, M.D., Ph.D.

Role: primary

15874179855

Other Identifiers

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nTMS

Identifier Type: -

Identifier Source: org_study_id

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