Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

January 19, 2010 updated by: The University of New South Wales

A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 2
Device: Sham
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily Voices Ratings (Mental Health Research Institute, Victoria)
Time Frame: Daily
Daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Collaborators

NSW Schizophrenia Fellowship
Rebecca Cooper Medical Research Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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