Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

This study builds on the results of a previous phase 1, single-site study in which we
demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the
cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.

The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis
on positive and negative symptoms of schizophrenia. A second, added goal is to investigate
the mechanisms of the expected clinical improvement.

Schizophrenia is a leading cause of mental disability and current treatments still remain
only partially successful for many patients. Our underlying hypothesis is that modulation of
the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and
emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and
produce clinical improvement.

Inclusion Criteria:

- Age between 18-65 years

- Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical
Manual) by a board-certified psychiatrist

Exclusion Criteria:

- Preexisting or progressive neurological disorders

- Prior neurological procedures

- Previous head injury

- Change in antipsychotic medication during the last 4 weeks

- Been an inpatient in a psychiatry clinic within the last month

- Any other axis 1 diagnosis

- Patients may not be actively enrolled in a separate intervention study

- Patients unable to undergo a brain MRI

- Any unstable medical condition

- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform_ EEG, or
family history of treatment resistant epilepsy

- Possible pregnancy. All female participants of child bearing age are required to have
a pregnancy test.

- Any metal in the brain, skull, or elsewhere unless approved by the responsible MD

- Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion
pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the
responsible MD

- Substance abuse (alcohol, amphetamines, cocaine, MDMA [methylenedioxymethamphetamine],
ecstasy, PCP [phencyclidine], Angle dust) or dependence within the past six months

- No medication is an absolute exclusion from TMS. Medications will be reviewed by the
responsible MD and a decision about inclusion will be made based on the following: the
patient's past medical history, drug dose, history of recent medication changes or
duration of treatment, and combination with other CNS (central nervous system) active
drugs (the published TMS guidelines review of medications to be considered with TMS)