Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatment repetitive transcranial magnetic stimulation
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Sidney R. Baer, Jr. Foundation
Start date February 2012
End date November 2015
Trial size 30 participants
Trial identifier NCT01551979, 2011P-000373

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
repetitive transcranial magnetic stimulation Transcranial Magnetic Stimulation
intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session. Sham participants will undergo the same procedures as those in the active rTMS group.
(Sham Comparator)
Sham rTMS to the vermis (lobule VII) of the cerebellum.
repetitive transcranial magnetic stimulation Transcranial Magnetic Stimulation
intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session. Sham participants will undergo the same procedures as those in the active rTMS group.

Primary Outcomes

Measure
Change from baseline on the Positive and Negative Symptoms Scale (PANSS)
time frame: 1 week before treatment, last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change from baseline on the Clinical Global Impression (CGI)
time frame: 1 week before treatment, last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment

Secondary Outcomes

Measure
Change in Profile of Mood States (POMS)
time frame: 1 week before treatment, last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change in Calgary Depression Scale for Schizophrenia
time frame: 1 week before treatment, last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change in Visual Analogue Scales (VAS)
time frame: 1 week before treatment, last day of treatment (after 5 days of treatment), 1 and 3 weeks post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Principal investigator Mark Halko, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.