rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients

National Taiwan University

Status

Enrolling

Conditions

Schizophrenia and Related Disorders

Treatments

Device: Repetitive Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05671185

202210011DINC

Details and patient eligibility

About

Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted.

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.

Enrollment

180 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 20 years
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

DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months
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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 4 patient groups

conventional rTMS

Experimental group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

iTBS

Experimental group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

sham rTMS

Sham Comparator group

Description:

target: left DLPFC sham probe, the same protocol as active conventional rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

sham iTBS

Sham Comparator group

Description:

target: left DLPFC sham probe, the same protocol as active iTBS