Suspended

Using Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia: a Randomized, Double-blinded, Sham-controlled Clinical Trial

What is being tested

Transcranial magnetic stimulation

+ Sham

Device

Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 20 to 45 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: September 2019

See protocol details

Summary

Principal SponsorNational Taiwan University Hospital

Study ContactYi-Ting Lin

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 5, 2019

Actual date on which the first participant was enrolled.

Auditory mismatch negativity deficit is a robust neurophysiological biomarker of schizophrenia. Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulation method and can be used to modulate excitability of specific brain cortical region. We hypothesize that MMN deficit of schizophrenia is related to inferior frontal gyrus (IFG) hypofunction, and this deficit can be improved by using rTMS to enhance IFG function. It is a randomized, double-blinded, sham-controlled clinical trial. Forty-eight schizophrenia patients with MMN deficits (mean amplitude at FCz > -0.7 ㎶) will be recruited and then randomized at a 1:1 ratio to rTMS group and sham-stimulation group. Subjects in rTMS group will receive high frequency rTMS over IFG, while in the other group subjects will receive sham stimulation at IFG. Frameless stereotaxy navigation will be used to guide the rTMS coil to IFG. The primary outcome is the change of MMN mean amplitude at FCz after stimulation. We hypothesize that the change of MMN mean amplitude is significantly larger in rTMS group than in sham-stimulation group. Their cognitive function and clinical condition will be evaluated carefully before and after experiments.

Official TitleUsing Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia: a Randomized, Double-blinded, Sham-controlled Clinical Trial

NCT04012684

Principal SponsorNational Taiwan University Hospital

Study ContactYi-Ting Lin

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

3 inclusion criteria required to participate

diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision

mean amplitude of MMN at FCz greater than -0.7 ㎶

moderate or milder disease severity (scoring 4 or below according to clinical global rating scale)

7 exclusion criteria prevent from participating

unwillingness or inability to cooperate with the experiments

with mental retardation, epilepsy, or other major brain pathology (e.g. cerebrovascular accidents or major head injury)

with alcohol or other illicit substance abuse

with major debilitating systemic diseases or difficulties in ambulation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

One-session rTMS is applied to left IFG. Pre-stimulation and post-stimulation MMN is recorded and compared. After at least two weeks, one-session rTMS is applied to right IFG. Pre-stimulation and post-stimulation MMN is recorded and compared as well.

Group II

Experimental

One-session rTMS is applied to right IFG. Pre-stimulation and post-stimulation MMN is recorded and compared. After at least two weeks, one-session rTMS is applied to left IFG. Pre-stimulation and post-stimulation MMN is recorded and compared as well. After at least two weeks, stimulations of the same parameters are given over left IFG. Pre-stimulation and post-stimulation MMN is recorded and compared as well.

Group III

Sham

One-session sham stimulation is applied to left IFG. Pre-stimulation and post-stimulation MMN is recorded and compared. After at least two weeks, one-session sham stimulation is applied to right IFG. Pre-stimulation and post-stimulation MMN is recorded and compared as well.

Group IV

Sham

One-session sham stimulation is applied to right IFG. Pre-stimulation and post-stimulation MMN is recorded and compared. After at least two weeks, one-session sham stimulation is applied to left IFG. Pre-stimulation and post-stimulation MMN is recorded and compared as well.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Psychiatry, National Taiwan University Hospital

Taipei, TaiwanOpen Department of Psychiatry, National Taiwan University Hospital in Google Maps

SuspendedOne Study Center