Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

January 4, 2012 updated by: Z. J. Daskalakis, Centre for Addiction and Mental Health

A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Magstim Rapid (Magstim Company Ltd., Wales, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychotic Symptoms Rating Scale (PSYRATS)
Time Frame: 4 weeks
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)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale - Global
Time Frame: 4 weeks
response on the global PANSS (30% reduction), PANSS global scale change
4 weeks
Positive and Negative Symptom Scale - Positive subscale
Time Frame: 4 weeks
response on the positive scale of the PANSS (30% reduction), PANSS positive scale change
4 weeks
Hallucination Change Scale
Time Frame: 4 weeks
response on the HCS (score < 5)
4 weeks
Auditory Hallucination Rating Scale (AHRS)
Time Frame: 4 weeks
response on the AHRS and change over time in the AHRS.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

National Alliance for Research on Schizophrenia and Depression
Canadian Institutes of Health Research (CIHR)
Ontario Mental Health Foundation

Investigators

  • Principal Investigator: Z J Daskalakis, MD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 127/2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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