The Mid-term Effect of Repeated Transcranial Magnetic Stimulation on Schizophrenia

NCT ID: NCT03940898

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-09-30

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

study group-active rTMS

Participants in the study group received 100%MT(motor threshold) repetitive transcranial magnetic stimulation with the intermittent theta burst stimulation paradigm.

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076. The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations. The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention. All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.

control group-shame rTMS

Participants in the control group received rTMS pseudo-stimulation intervention. The stimulation head was inverted by 180 degrees or 90 degrees according to the model of the stimulation device to achieve pseudo-stimulation and the remaining stimulation parameters were consistent with the study group.

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076. The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations. The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention. All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.

Interventions

repetitive transcranial magnetic stimulation

There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076. The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations. The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention. All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Cai

Role: STUDY_DIRECTOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, , China

Countries

China

Other Identifiers

JCai

Identifier Type: -

Identifier Source: org_study_id