UnknownNot Applicable

Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

China90 participantsStarted 2020-01-01

Plain-language summary

Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.

Who can participate

Age range

18 Years – 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: * Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 . * Age between 18 and 60. * Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥4. * All patients were in stable clinical conditions (reduction rate of PANSS score\<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent. Exclusion Criteria: * Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension). * Unstable clinical condition (e.g., being aggressive and uncooperative). * Current substance abuse. * Any other psychiatric diagnosis. * Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases. * Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.

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

Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment

Timeframe: Baseline and 4 weeks

Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment

Timeframe: Baseline and 4 weeks

Trial details

NCT IDNCT05599373

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Yan Zhan, MD

18917757626 jyzyan136@163.com

View on ClinicalTrials.gov More Schizophrenia trials