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Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551979
First Posted: March 13, 2012
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sidney R. Baer, Jr. Foundation
Information provided by (Responsible Party):
Mark Halko, Beth Israel Deaconess Medical Center
March 1, 2012
March 13, 2012
March 15, 2017
June 2, 2017
June 2, 2017
February 2012
November 2015   (Final data collection date for primary outcome measure)
  • Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subcale [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
    Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
    Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subcale [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
    Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
    Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • Clinical Global Impression (CGI) Global Improvement [ Time Frame: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
    Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • 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 ]
    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 ]
    A three item scale used to assess treatment response in psychiatric patients. They are: Severity of Illness; Global Improvement, and Efficacy Index.
Complete list of historical versions of study NCT01551979 on ClinicalTrials.gov Archive Site
Change From Baseline on the Calgary Depression Scale for Schizophrenia [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]
The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
  • 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 ]
    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 ]
    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 ]
    Subjective measurements that will measure characteristics over a continuum to assess for change within the individual subjects.
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
 
Completed
22
November 2015
November 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01551979
2011P000373
No
Not Provided
Not Provided
Mark Halko, 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
May 2017

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