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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).
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Shanghai Mental Health Center
Shanghai, China
Start Date
July 1, 2017
Primary Completion Date
September 30, 2018
Completion Date
September 30, 2018
Last Updated
May 7, 2019
64
ACTUAL participants
repetitive transcranial magnetic stimulation
DEVICE
Lead Sponsor
Shanghai Mental Health Center
NCT07455929
NCT06740383
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