Clinical trial NCT03940898: The Mid-term Effect of Repeated Transcranial Magnetic Stimulation on Schizophrenia
Official title: A Follow-up Study of Clinical Effects of Repetitive Transcranial Magnetic Stimulation on Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Repetitive transcranial magnetic stimulation
Schizophrenia
Cerebellar vermis
Negative symptoms
Depressive symptoms
Cognitive function
Follow-up study
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* the patient met the diagnostic criteria for schizophrenia in ICD-10;
* 18-50 years old;
* Right handed;
* The current condition is stable, and the types and doses of antipsychotic drugs are unchanged;
* In the PANSS scale, the score of Pl, P3, P5, P6, and G9 is not more than 5 points, and the score of P2 is not more than 4 points;

Exclusion Criteria:

* In addition to schizophrenia, patients with other mental illnesses；
* Contraindications to rTMS;
* Patients receiving ECT(electro-convulsive therapy) in last month;
* Pregnant or lactating woman.

Primary outcomes:
measure: PANSS-N
timeFrame: 24 weeks
Secondary outcomes:
measure: MCCB
timeFrame: 24 weeks
measure: HAMD-24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Jun Cai
role: STUDY_DIRECTOR
References: