rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
NCT ID: NCT05671185
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-12-01
2025-12-31
Brief Summary
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Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (\>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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conventional rTMS
target: left DLPFC
protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total
Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
iTBS
target: left DLPFC
protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total
Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
sham rTMS
target: left DLPFC
sham probe, the same protocol as active conventional rTMS
Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
sham iTBS
target: left DLPFC
sham probe, the same protocol as active iTBS
Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
Interventions
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Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent
* Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5
* Has a score ≥ 7 on Calgary depression scale for schizophrenia
* The principal psychotropic agents are not changed within one month of the first session of rTMS
Exclusion Criteria
* Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE \< 15)
* With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \[ICD\], cerebral shunts, cochlear implant, etc.)
* With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)
* Pregnant, or has a pregnancy plan within 3 months
* With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion
* Received rTMS or iTBS treatment within 3 months
* Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chia-Hao Ma, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Locations
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Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chia-Hao Ma, MD
Role: primary
Other Identifiers
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202210011DINC
Identifier Type: -
Identifier Source: org_study_id