Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

This study has been completed.

Sponsor:

Collaborators:

NSW Schizophrenia Fellowship

Rebecca Cooper Medical Research Foundation

Information provided by:

The University of New South Wales

ClinicalTrials.gov Identifier:

NCT00763841

First received: September 30, 2008

Last updated: January 19, 2010

Last verified: November 2009

History of Changes

Purpose

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	Intervention	Phase
Auditory Hallucinations	Device: Transcranial magnetic stimulation Device: Sham	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:

Daily Voices Ratings (Mental Health Research Institute, Victoria) [ Time Frame: Daily ] [ Designated as safety issue: No ]


Estimated Enrollment:	18
Study Start Date:	September 1999
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763841

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


Responsible Party:	Assoc. Prof. Colleen Loo, University of NSW
ClinicalTrials.gov Identifier:	NCT00763841 History of Changes
Other Study ID Numbers:	07019
Study First Received:	September 30, 2008
Last Updated:	January 19, 2010
Health Authority:	Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 27, 2016

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