Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

NCT ID: NCT01386918

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-01-31

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).

Conditions

Refractory Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

The treatment involves the administration of a magnetic field applied to a specific area of the brain.

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.

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

The treatment involves the administration of a magnetic field applied to a specific area of the brain.

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.

Group Type: SHAM_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

The treatment involves the administration of a magnetic field applied to a specific area of the brain.

Interventions

repetitive Transcranial Magnetic Stimulation

The treatment involves the administration of a magnetic field applied to a specific area of the brain.

Intervention Type: DEVICE

Other Intervention Names

Magstim Rapid (Magstim Company Ltd., Wales, UK)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Z. J. Daskalakis

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Z J Daskalakis, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22410480 (View on PubMed)

Related Links

http://www.camh.net/research

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

Other Identifiers

127/2003

Identifier Type: -

Identifier Source: org_study_id