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Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

Primary Purpose

Auditory Hallucinations

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Transcranial magnetic stimulation

Sham

About this trial

This is an interventional treatment trial for Auditory Hallucinations focused on measuring Auditory hallucinations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

School of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

Stimulation will be given daily at a particular site for three days a week

Outcomes

Primary Outcome Measures

Daily Voices Ratings (Mental Health Research Institute, Victoria)

Secondary Outcome Measures

Full Information

NCT ID

NCT00763841

First Posted

September 30, 2008

Last Updated

January 19, 2010

Sponsor

The University of New South Wales

Collaborators

NSW Schizophrenia Fellowship, Rebecca Cooper Medical Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00763841

Brief Title

Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

September 1999 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of New South Wales

Collaborators

NSW Schizophrenia Fellowship, Rebecca Cooper Medical Research Foundation

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Auditory Hallucinations

Keywords

Auditory hallucinations

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Stimulation will be given daily at a particular site for three days a week

Arm Title

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial magnetic stimulation

Intervention Description

Stimulation will be given daily at a particular site for three days a week

Intervention Type

Device

Intervention Name(s)

Sham

Primary Outcome Measure Information:

Title

Daily Voices Ratings (Mental Health Research Institute, Victoria)

Time Frame

Daily

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen Loo, MBBS, FRANZCP. MD

Organizational Affiliation

University of NSW

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Psychiatry

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

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