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rTMS on Mismatch Negativity of Schizophrenia
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Mismatch Negativity | Device: Transcranial magnetic stimulation Device: Sham | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Using Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia: a Randomized, Double-blinded, Sham-controlled Clinical Trial |
| Actual Study Start Date : | September 5, 2019 |
| Estimated Primary Completion Date : | February 28, 2021 |
| Estimated Study Completion Date : | February 28, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: rTMS: left first
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.
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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.
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Experimental: rTMS: right first
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
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.
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Sham Comparator: Sham: left first
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
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 Comparator: Sham: right first
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
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.
|
- Mismatch negativity (MMN) [ Time Frame: 1 day ]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.
- Continuous performance test (CPT) [ Time Frame: 1 day ]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).
- Wisconsin Card Sorting Test (WCST) [ Time Frame: 1 day ]Four indices of WCST are derived: perseverative errors, categories achieved, trials to complete first category, and conceptual level response.
| Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Yi-Ting Lin | +886-23123456 ext 67990 | yit.lin@gmail.com |
| Taiwan | |
| Department of Psychiatry, National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 1002 | |
| Contact: Yi-Ting Lin, MD 886-2-23123456 ext 67990 yit.lin@gmail.com | |
| Principal Investigator: Yi-Ting Lin, MD | |
| Sub-Investigator: Ming H. Hsieh, MD, PhD | |
| Sub-Investigator: Chih-Min Liu, MD, PhD | |
| Sub-Investigator: Cheng-Chung Liu, MD, PhD | |
| Sub-Investigator: Yi-Ling Chien, MD, PhD | |
| Sub-Investigator: Tzung-Jeng Hwang, MD, PhD | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 7, 2019 | ||||
| First Posted Date ICMJE | July 9, 2019 | ||||
| Last Update Posted Date | August 10, 2020 | ||||
| Actual Study Start Date ICMJE | September 5, 2019 | ||||
| Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mismatch negativity (MMN) [ Time Frame: 1 day ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | rTMS on Mismatch Negativity of Schizophrenia | ||||
| Official Title ICMJE | Using Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia: a Randomized, Double-blinded, Sham-controlled Clinical Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
48 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 28, 2021 | ||||
| Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04012684 | ||||
| Other Study ID Numbers ICMJE | 201807026RINB | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | National Taiwan University Hospital | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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