Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04012684
Other study ID # 201807026RINB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 5, 2019
Est. completion date February 28, 2021

Study information

Verified date August 2020
Source National Taiwan University Hospital
Contact Yi-Ting Lin
Phone +886-23123456
Email yit.lin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial magnetic stimulation
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.
Sham
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.

Locations

Country Name City State
Taiwan Department of Psychiatry, National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Continuous performance test (CPT) The undegraded 1-9 task and the 25% degraded 1-9 task are used. Sensitivity indices indicating the ability to discriminate target from non-target trials are calculated (d' for undegraded CPT and md' for degraded CPT). 1 day
Secondary Wisconsin Card Sorting Test (WCST) Four indices of WCST are derived: perseverative errors, categories achieved, trials to complete first category, and conceptual level response. 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1