Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Sidney R. Baer, Jr. Foundation
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01551979
First received: March 1, 2012
Last updated: October 15, 2014
Last verified: October 2014

March 1, 2012
October 15, 2014
February 2012
January 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
    Evaluates the presence/absence and severity of positive, negative, and general psychopathology of schizophrenia.
  • 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 ] [ Designated as safety issue: No ]
    A three item scale used to assess treatment response in psychiatric patients. They are: Severity of Illness; Global Improvement, and Efficacy Index.
Same as current
Complete list of historical versions of study NCT01551979 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Assessment of transient, fluctuating mood states.
  • 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 ] [ Designated as safety issue: No ]
    Specifically developed for assessment of depression in patients with schizophrenia.
  • 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 ] [ Designated as safety issue: No ]
    Subjective measurements that will measure characteristics over a continuum to assess for change within the individual subjects.
Same as current
Not Provided
Not Provided
 
Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Device: Repetitive 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.

Other Names:
  • Transcranial Magnetic Stimulation
  • Noninvasive Brain Stimulation
  • Active Comparator: Active rTMS
    High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
  • Sham Comparator: Sham rTMS
    Sham rTMS to the vermis (lobule VII) of the cerebellum.
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18-65 years
  • Diagnosis of schizophrenia according to DSM-IV criteria (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, ecstasy, PCP, 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 active drugs (the published TMS guidelines review of medications to be considered with TMS)
Both
18 Years to 65 Years
No
Contact: Mark Halko, Ph.D. 617-667-0367 mhalko@bidmc.harvard.edu
Contact: Irene Gonsalvez, M.D. 617-667-0181 igonsalv@bidmc.harvard.edu
United States
 
NCT01551979
2011P-000373
No
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Sidney R. Baer, Jr. Foundation
Principal Investigator: Mark Halko, Ph.D. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP