Clinical trial NCT01551979: Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
Official title: Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
repetitive Transcranial Magnetic Stimulation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Sidney R. Baer, Jr. Foundation
First posted: 2012-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies. If the investigators trial were to show beneficial effects, its clinical significance would be great.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
timeFrame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
measure: Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
timeFrame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
measure: Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
timeFrame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
measure: Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
timeFrame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
measure: Clinical Global Impression (CGI) Global Improvement
timeFrame: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Secondary outcomes:
measure: Change From Baseline on the Calgary Depression Scale for Schizophrenia
timeFrame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Mark Halko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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