RecruitingNot Applicable

nTMS for Negative Symptom in Schizophrenia

China40 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Positive and Negative Symptom Scale (PANSS) score

Timeframe: 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

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

Trial details

NCT IDNCT06642675

SponsorCentral South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

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

15874179855 wurenrong2013@163.com

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Positive and Negative Symptom Scale (PANSS) score

Timeframe: 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

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