Repetitive Transcranial Magnetic Stimulation for Refractory Auditory Hallucinations in Schizophrenia

Not Applicable

Completed

• Conditions: Refractory Schizophrenia
• Interventions: Device: repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT01386918
• Lead Sponsor: Centre for Addiction and Mental Health

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low frequency left (LFL) sided rTMS	repetitive Transcranial Magnetic Stimulation	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	repetitive Transcranial Magnetic 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.
Sham Control	repetitive Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Psychotic Symptoms Rating Scale (PSYRATS)	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada