NCT04012684

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

July 7, 2019

Last Update Submit

August 6, 2020

Conditions

SchizophreniaMismatch Negativity

Keywords

Repetitive transcranial stimulationInferior frontal gyrus

Outcome Measures

Primary Outcomes (1)

  • Mismatch negativity (MMN)

    Mismatch negativity is recorded by electroencephalography and elicited by auditory oddball paradigm in which tone duration deviants are used. MMN is the mean amplitude between 135 and 205 milliseconds after auditory stimuli recorded by electrode FCz.

    1 day

Secondary Outcomes (2)

  • Continuous performance test (CPT)

    1 day

  • Wisconsin Card Sorting Test (WCST)

    1 day

Study Arms (4)

rTMS: left first

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.

Device: Transcranial magnetic stimulation

rTMS: right first

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.

Device: Transcranial magnetic stimulation

Sham: left first

SHAM COMPARATOR

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.

Device: Sham

Sham: right first

SHAM COMPARATOR

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.

Device: Sham

Interventions

Transcranial magnetic stimulationDEVICE

For one-session rTMS, 50 trains of stimulation are given. Each train is consisted of 4-second 10 Hz, 100% resting motor threshold TMS pulses. The inter-train interval is 26 seconds.

rTMS: left firstrTMS: right first
ShamDEVICE

For one-session sham stimulation, 50 trains of stimulation are given. Each train is consisted of 4-second 10 Hz sham pulses. The inter-train interval is 26 seconds.

Sham: left firstSham: right first

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • with hearing impairments as screened by audiometry over 500 Hz, 1000 Hz and 6000 Hz
  • with pacemaker, intra-ocular metal foreign body, intracerebral vessel clip, artificial cardiac valve, electronic implant in the body, claustrophobia, or previous surgery involving the brain
  • being pregnant or to be pregnant during the clinical trial. A pre-TMS evaluation scale will be applied to ensure the safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, 1002, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Yi-Ting Lin

CONTACT

+886-23123456yit.lin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 9, 2019

Study Start

September 5, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

TW(1)