A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal
      cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal
      activity in this region in patients experiencing negative symptoms. Finally rTMS applied at
      high frequency shows the capacity to up-regulate cortical activity in a way that would
      provide an explanation for a therapeutic response.

      The study involves participants receiving 15 sessions of high frequency rTMS treatment
      applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following
      this double blind phase, participants randomised to placebo treatment will be offered 15
      sessions of active treatment.

      In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and
      after completion of the course, as a means of measuring cortical inhibition and facilitation.
      NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the
      first and last treatment sessions to allow monitoring of oxygenated and deoxygenated
      haemoglobin.
    

Detailed description: 
      The main outcome measure used is the SANS (Scale for the Assessment of Negative Symptoms.
      This is a semi strucutured interview which provides scores from 0-70. This is administered at
      baseline, week 2, 3, 5 and 6.

      Other outcome measures administered are (frequency mentioned above): PANSS (Positive and
      Negative Syndrome Scale) and the Calgery Depression Scale for Schizophrenia, A cognitive
      battery is also administered.

      Inclusion Criteria:

        -  Diagnostic and Statistical Manual-IV diagnosis of schizophrenia or schizoaffective
           disorder, age over 18

        -  Persistent negative symptoms of moderate to severe intensity

        -  Failure to respond to a minimum of two antipsychotic medications

        -  No increase or initiation of new antipsychotic therapy in the four weeks prior to
           entering the trial Exclusion Criteria

        -  Prominent positive symptoms

        -  Have an unstable medical condition, neurological disorder or any history of seizure
           disorder or are currently pregnant or lactating

        -  Previous brain injury or surgery, any metal clips, plates or other metal items in the
           head, cardiac pacemaker

        -  Subjects at high risk of violence or suicide as determined by the investigator and
           treating clinicians

        -  Substance dependence
    

Intervention name(s): Transcranial Magnetic Stimulation; sham TMS
Intervention type(s): Device; Device
Intervention description(s): Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Schizophrenia; Negative Symptoms