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Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Primary Purpose

Refractory Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Schizophrenia focused on measuring Hallucinations, Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Low frequency left (LFL) sided rTMS

Priming stimulation

Sham Control

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Psychotic Symptoms Rating Scale (PSYRATS)
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
response on the global PANSS (30% reduction), PANSS global scale change
Positive and Negative Symptom Scale - Positive subscale
response on the positive scale of the PANSS (30% reduction), PANSS positive scale change
Hallucination Change Scale
response on the HCS (score < 5)
Auditory Hallucination Rating Scale (AHRS)
response on the AHRS and change over time in the AHRS.

Full Information

First Posted
June 29, 2011
Last Updated
January 4, 2012
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation, Canadian Institutes of Health Research (CIHR), National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT01386918
Brief Title
Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
Official Title
A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation, Canadian Institutes of Health Research (CIHR), National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Schizophrenia
Keywords
Hallucinations, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low frequency left (LFL) sided rTMS
Arm Type
Experimental
Arm Description
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).
Arm Title
Priming stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
Magstim Rapid (Magstim Company Ltd., Wales, UK)
Intervention Description
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Primary Outcome Measure Information:
Title
Psychotic Symptoms Rating Scale (PSYRATS)
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Symptom Scale - Global
Description
response on the global PANSS (30% reduction), PANSS global scale change
Time Frame
4 weeks
Title
Positive and Negative Symptom Scale - Positive subscale
Description
response on the positive scale of the PANSS (30% reduction), PANSS positive scale change
Time Frame
4 weeks
Title
Hallucination Change Scale
Description
response on the HCS (score < 5)
Time Frame
4 weeks
Title
Auditory Hallucination Rating Scale (AHRS)
Description
response on the AHRS and change over time in the AHRS.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Z J Daskalakis, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22410480
Citation
Blumberger DM, Christensen BK, Zipursky RB, Moller B, Chen R, Fitzgerald PB, Daskalakis ZJ. MRI-targeted repetitive transcranial magnetic stimulation of Heschl's gyrus for refractory auditory hallucinations. Brain Stimul. 2012 Oct;5(4):577-85. doi: 10.1016/j.brs.2011.12.002. Epub 2012 Feb 22.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre

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Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

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