Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

Beth Israel Lahey Health

Status

Completed

Conditions

Schizophrenia

Treatments

Device: Repetitive Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01551979

2011P000373

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)