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Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00763841
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 20, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
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

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
Primary Completion Date : September 2008
Study Completion Date : September 2008
Arms and Interventions

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 1, 2008    Key Record Dates
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