The Mid-term Effect of Repeated Transcranial Magnetic Stimulation on Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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).
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive transcranial magnetic stimulation; Schizophrenia; Cerebellar vermis; Negative symptoms; Depressive symptoms; Cognitive function; Follow-up study