Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
A Randomized Double-Blind Sham-Controlled Trial of Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia
1 other identifier
interventional
144
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedJanuary 6, 2012
January 1, 2012
4.9 years
June 29, 2011
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
4 weeks
Secondary Outcomes (4)
Positive and Negative Symptom Scale - Global
4 weeks
Positive and Negative Symptom Scale - Positive subscale
4 weeks
Hallucination Change Scale
4 weeks
Auditory Hallucination Rating Scale (AHRS)
4 weeks
Study Arms (3)
Low frequency left (LFL) sided rTMS
EXPERIMENTALLFL 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
EXPERIMENTALPriming 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 Control
SHAM COMPARATORSham 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.
Interventions
The treatment involves the administration of a magnetic field applied to a specific area of the brain.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Publications (1)
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.
PMID: 22410480DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Z J Daskalakis, MD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 1, 2011
Study Start
February 1, 2004
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
January 6, 2012
Record last verified: 2012-01