Clinical trial NCT04012684: rTMS on Mismatch Negativity of Schizophrenia
Official title: Using Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia: a Randomized, Double-blinded, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Mismatch Negativity
Keywords: Repetitive transcranial stimulation
Inferior frontal gyrus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mismatch negativity (MMN)
timeFrame: 1 day
Secondary outcomes:
measure: Continuous performance test (CPT)
timeFrame: 1 day
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Psychiatry, National Taiwan University Hospital
Study officials:
References: