Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively stimulate the brain. Studies overseas have suggested this may be an effective and safe treatment for auditory hallucinations in patients with schizophrenia. This is a sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory hallucinations in patients with schizophrenia.

Condition or disease	Intervention/treatment	Phase
Auditory Hallucinations	Device: Transcranial magnetic stimulation; Device: Sham	Phase 1

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	18 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations
Study Start Date :	September 1999
Actual Primary Completion Date :	September 2008
Actual Study Completion Date :	September 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Stimulation will be given daily at a particular site for three days a week	Device: Transcranial magnetic stimulation; Stimulation will be given daily at a particular site for three days a week
Sham Comparator: 2	Device: Sham

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Daily Voices Ratings (Mental Health Research Institute, Victoria) [ Time Frame: Daily ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Over 18, with DSM-IV diagnosis of Schizophrenia and auditory hallucinations of clear external origins, refractory to pharmacotherapy and occurring at least 5 times per day.

Exclusion Criteria:

• Subjects with contraindications to TMS (e.g. epilepsy, pacemaker) or those with an unacceptably high risk (e.g. suicide risk) will be excluded from the study.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Australia, New South Wales
School of Psychiatry
Sydney, New South Wales, Australia, 2031

Sponsors and Collaborators

The University of New South Wales

NSW Schizophrenia Fellowship

Rebecca Cooper Medical Research Foundation

Investigators

Principal Investigator:	Colleen Loo, MBBS, FRANZCP. MD	University of NSW

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assoc. Prof. Colleen Loo, University of NSW
ClinicalTrials.gov Identifier:	NCT00763841 History of Changes
Other Study ID Numbers:	07019
First Posted:	October 1, 2008
Last Update Posted:	January 20, 2010
Last Verified:	November 2009

Keywords provided by The University of New South Wales:

Auditory hallucinations

Additional relevant MeSH terms:

Hallucinations; Perceptual Disorders; Neurobehavioral Manifestations	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms