Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

This study is ongoing, but not recruiting participants.
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: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Device: Repetitive Transcranial Magnetic Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: February 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active rTMS
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
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
Sham Comparator: Sham rTMS
Sham rTMS to the vermis (lobule VII) of the cerebellum.
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551979

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02134
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Sidney R. Baer, Jr. Foundation
Investigators
Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01551979     History of Changes
Other Study ID Numbers: 2011P-000373
Study First Received: March 1, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Schizophrenia
repetitive Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014