Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
Condition: Schizophrenia; Functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      To investigate the treatment effect of intermittent theta-burst transcranial magnetic
      stimulation on symptomatic relief of schizophrenia patients, and the underlying neural
      mechanism by functional MRI and the resting electroencephalogram
    

Detailed description: 
      All patients underwent a medical evaluation that included physical examination and routine
      laboratory studies before and after intermittent theta-burst transcranial magnetic
      stimulation (iTBS) treatment. Patients were randomly allocated to iTBS group and the sham
      group by coin toss. There are about 30 patients in each group.The decision to enroll a
      patient was always made prior to randomization. Patients were studied using a double-blind
      design. Study participants, clinical raters, and all personnel responsible for the clinical
      care of the patient remained masked to allocated condition and allocation parameters. Only
      iTBS administrators had access to the randomization list; they had minimal contact with the
      patients, and no role in assessing the Positive and Negative Syndrome Scale (PANSS). Each
      patient would be treated for continuous 14 days by iTBS.Before the iTBS treatment, PANSS and
      Clinical Global Impression-severity of illness (CGI-SI) at baseline were obtained by a
      trained investigator to assess baseline severity of their symptoms. Scale for the Assessment
      of Negative Symptoms (SANS) and Scale for Assessment of Positive Symptoms (SAPS) were
      respectively supplemented to evaluate the severity of symptoms in different dimensions,.The
      patients had receiving a battery measure of neuropsychological tests (standardized tests to
      investigate their cognitive problems, anxiety and depressive symptoms in daily life),
      magnetic resonance imaging scan in multimodalities, electroencephalography (EEG),
      event-related potentials during stop signal test and Iowa-gambling test record. Other
      behavioral tests including intertemporal decision,spatial n-back test record.

      After the last treatment, the Positive and Negative Syndrome Scale were obtained, as well as
      the Global Index of Safety to assess adverse events of the treatment. Patients were
      instructed to focus their answers on the past 14 days. The patients had also receiving a
      battery measure of neuropsychological tests, magnetic resonance imaging scan in
      multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI),
      Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.

      40-60 days after the last treatment, participants were interviewed to obtain the Positive and
      Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. They were instructed to focus their answers
      on the past week. Additionally, they were also asked to assess the battery of
      neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and
      EEG record. Afterwards, they were unblinded by the study coordinator.
    

Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): The stimulations were performed by MagStim Rapid2. Participants in active comparator will receive active transcranial magnetic stimulation(Real Stimulation) daily for two weeks.
Participants in sham comparator will receive no stimulation(Sham Stimulation) daily for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment