nTMS for Negative Symptom in Schizophrenia

NCT06642675 | Recruiting

• 1 other identifier: nTMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; TMS; negative symptom

Outcome Measures

Primary Outcomes (2)

• Change in Positive and Negative Symptom Scale (PANSS) score

  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)

• Change in Scale for Assessment of Negative Symptoms(SANS) score

  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)

Secondary Outcomes (8)

• Change in MATRICS Consensus Cognitive Battery (MCCB) score

  Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)

• The data of head resting-state functional magnetic resonance imaging

  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

  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

  Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)

• Change of electroencephalogram

  Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)

Study Arms (2)

experimental group: active iTBS

EXPERIMENTAL

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)

control group: sham iTBS

SHAM COMPARATOR

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

Interventions

Sham stimulation 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.

control group: sham iTBS

Intermittent theta burst stimulation(iTBS) 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.

Also known as: Navigated transcranial magnetic stimulation (nTMS)

experimental group: active iTBS

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
• 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.
• 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.
• Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
• Severe risk of self-injury or suicide
• Other conditions where the researchers find unsuitable for the treatment

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Renrong Wu, M.D., Ph.D.

  Mental Health Institute of Second Xiangya Hospital,CSU

  STUDY CHAIR

Central Study Contacts

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

CONTACT

15874179855; wurenrong2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 22, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)