Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

Auditory Hallucinations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763841
• Other study ID #: 07019
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2008
• Last updated: January 19, 2010
• Start date: September 1999
• Est. completion date: September 2008

Study information

• Verified date: November 2009
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations

Intervention

Device:
• Transcranial magnetic stimulation
Stimulation will be given daily at a particular site for three days a week
• Sham

Locations

Country	Name	City	State
Australia	School of Psychiatry	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
The University of New South Wales	NSW Schizophrenia Fellowship, Rebecca Cooper Medical Research Foundation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Voices Ratings (Mental Health Research Institute, Victoria)		Daily	No