Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Phase 4

• Conditions: Schizophrenia
• Interventions: Device: Paired Pulse

• Registration Number: NCT00186771
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients.

Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. TMS is capable of inducing changes in the electrical activities of the brain in humans.

The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in schizophrenia.

Detailed Description

We hypothesize that: True treatment with rTMS will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex.

FMRI will highlight areas of activation with auditory hallucinations distinct from the area identified by Hoffman's scalp based method.

Cortical inhibition as measured by paired pulse TMS will be increased after true TMS but not sham TMS.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-27
• Last Update Posted: 2011-07-28
• Primary Completion: 2012-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Schizophrenia
• Auditory hallucinations occuring more than 5 times per day
• Adequate (6 weeks) trial of antipsychotic medication
• Including at least 1 atypical antipsychotic medication
• Medication stable for 4 weeks prior to commencement of the study
• Competent to consent

Exclusion Criteria

• history of seizure disorder in patient or first degree relative
• recent head injury
• Acute suicidality
• Alcohol or substance abuse
• Implanted pacemaker or metal in head or neck
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
True Transcranial Magnetic Stimulation	Paired Pulse	True treatment with TMS over the temporoparietal cortex.
Sham Transcranial Magnetic Stimulation	Paired Pulse	Sham treatment with rTMS over the temporoparietal cortex.

Primary Outcome Measures

Name	Time	Method
Hoffman Auditory Hallucination Scale	weekly	A series of 7 questions to identify the intensity and severity of the hallucinations

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	2 weeks

Trial Locations

Locations (1)

St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street; 🇨🇦 Hamilton, Ontario, Canada