Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Ontario Mental Health Foundation
Canadian Institutes of Health Research (CIHR)
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01386918
First received: June 29, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

Studies using repetitive transcranial magnetic stimulation (rTMS) as a treatment for refractory auditory hallucinations (AH) in schizophrenia have shown promise. The majority of studies have examined the effect of low frequency left-sided stimulation (LFL) (i.e., 1 Hz) to the temporal parietal cortex (TPC). Priming stimulation (6 Hz) prior to LFL stimulation (hereby simply referred to as priming) has been shown to enhance the neurophysiological effects of LFL rTMS alone and, as such, may lead to greater attenuation of AH. Therefore, this study evaluated the efficacy of priming rTMS and LFL rTMS, compared to sham, applied to the TPC in patients with schizophrenia experiencing refractory auditory hallucinations (AH).


Condition Intervention
Refractory Schizophrenia
Device: repetitive Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Psychotic Symptoms Rating Scale (PSYRATS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary outcome for this study was response (dichotomous outcome), defined as a 30 percent reduction in the composite score derived from the frequency, duration, loudness and content items of the hallucinations subscale of the Psychotic Symptoms Rating Scale (PSYRATS)


Secondary Outcome Measures:
  • Positive and Negative Symptom Scale - Global [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    response on the global PANSS (30% reduction), PANSS global scale change

  • Positive and Negative Symptom Scale - Positive subscale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    response on the positive scale of the PANSS (30% reduction), PANSS positive scale change

  • Hallucination Change Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    response on the HCS (score < 5)

  • Auditory Hallucination Rating Scale (AHRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    response on the AHRS and change over time in the AHRS.


Enrollment: 144
Study Start Date: February 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low frequency left (LFL) sided rTMS
LFL rTMS was administered at an intensity of 115% resting motor threshold at 1HZ for 20 minutes. The treatment targeted the left temporoparietal cortex (TPC).
Device: repetitive Transcranial Magnetic Stimulation
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Other Name: Magstim Rapid (Magstim Company Ltd., Wales, UK)
Experimental: Priming stimulation
Priming stimulation was administered as follows: 10 minutes of 6 Hz at 90% resting motor threshold (RMT) administered to the left temporoparietal cortex followed by 10 minutes of 1 Hz stimulation at 115% RMT.
Device: repetitive Transcranial Magnetic Stimulation
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Other Name: Magstim Rapid (Magstim Company Ltd., Wales, UK)
Sham Comparator: Sham Control
Sham stimulation was applied with identical parameters to those for the LFL condition but with the coil angled at 90 degrees off the scalp in a single wing tilt position.
Device: repetitive Transcranial Magnetic Stimulation
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Other Name: Magstim Rapid (Magstim Company Ltd., Wales, UK)

  Eligibility

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

Inclusion Criteria:

  • voluntary and capable to consent based on the subject's ability to provide a spontaneous narrative description of the key elements of the study
  • have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
  • between the ages of 18 and 65
  • meet criteria for AH of at least moderate severity based on the Positive and Negative Symptom Scale (PANSS)
  • willing to keep the dose of antipsychotic stable for the duration of the study
  • meet criteria for medication resistance, defined as daily AH despite 2 adequate 6-week trials of at least 2 antipsychotic medications and including 1 atypical antipsychotic medication. An adequate trial is defined as a daily dose of 1000 chlorpromazine equivalents for typical antipsychotics medications and the following dosages for atypical antipsychotic medications: risperidone 6 mg, olanzapine 15 mg, quetiapine 500 mg, clozapine 300 mg.

Exclusion Criteria:

  • DSM-IV history of alcohol and/or substance abuse in past month, or alcohol and/or substance dependence in the last 6 months
  • presence of concomitant major, unstable medical or neurologic illness, or a history of seizures
  • are pregnant
  • have received rTMS for any reason in the past
  • have had a dose change of usual psychotropic medications in the 4 weeks preceding study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386918

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Mental Health Foundation
Canadian Institutes of Health Research (CIHR)
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Z J Daskalakis, MD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided by Centre for Addiction and Mental Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Z. J. Daskalakis, Dr., Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01386918     History of Changes
Other Study ID Numbers: 127/2003
Study First Received: June 29, 2011
Last Updated: January 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Hallucinations
Schizophrenia

Additional relevant MeSH terms:
Hallucinations
Schizophrenia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014