nTMS for Negative Symptom in Schizophrenia

NCT06642675 · tracked via the Priya Life Science China tracker

Sponsor

Central South University

Phase

Not applicable

Started

2024-11-22

Last updated

2025-12-05

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Intermittent theta burst stimulation(iTBS)Sham stimulation

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in Positive and Negative Symptom Scale (PANSS) score — 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.
Change in Scale for Assessment of Negative Symptoms(SANS) score — 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.

Trial sites (1)

Facility	City	Region	Status
Mental Health Institute of Second Xiangya Hospital,CSU	Changsha	Hunan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642675 on ClinicalTrials.gov ↗ ← All trials in China