Schizophrenia Clinical Trial
Official title:
A Follow-up Study of Clinical Effects of Repetitive Transcranial Magnetic Stimulation on Schizophrenia
Medications have a poor effect on negative symptoms and cognitive function in schizophrenia. In the past, most of the studies on repetitive transcranial magnetic stimulation intervention in patients with schizophrenia used conventional stimulation sites and patterns, and the intervention effect was still controversial. A few studies have achieved positive results with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis), but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in China. Therefore, this study hypothesized that the TBS-mode rTMS intervention in the cerebellar vermis can improve the negative symptoms, cognitive function, and depressive symptoms of schizophrenia, and the efficacy can be maintained.
Medications have a poor effect on negative symptoms and cognitive function in schizophrenia.
In the past, most of the studies on repetitive transcranial magnetic stimulation intervention
in patients with schizophrenia used conventional stimulation sites and patterns, and the
intervention effect was still controversial. A few studies have achieved positive results
with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis),
but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in
China. Therefore, this study hypothesized that the TBS-mode rTMS intervention in the
cerebellar vermis can improve the negative symptoms, cognitive function, and depressive
symptoms of schizophrenia, and the efficacy can be maintained.
1. Aim of the study: 1.1 To explore the clinical efficacy of cerebellar vermal theta burst
stimulation for negative symptoms, cognitive function and depressive symptoms in
patients with schizophrenia. 1.2 The patients were followed up for 24 weeks to explore
the duration of rTMS efficacy
2. Introduction of the study: This is a multi-center, randomized, sham-controlled,
double-blinded trial. Participants diagnosed with schizophrenia from Shanghai Mental
Health Center and six district-level mental health centers were randomized according to
the odd-even sequence of enrollment, with odd numbers into the study group and even
numbers into the control group. Patients in the study group received 100%MT rTMS with
the intermittent theta burst stimulation paradigm, while another patients were subjected
to pseudo-stimulation treatment, both being given 2-week intervention (5 times per
week). The type and dose of antipsychotic drugs taken by patients remained unchanged
during the intervention period. Efficacy were assessed with the Positive and Negative
Symptoms Scale (PANSS), Hamilton Depression Scale (HAMD-24) and MATRICS Consensus
Cognitive Battery (MCCB).
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