Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations
Sponsor
The University of New South Wales (Other)
Overall Status
Completed
CT.gov ID
NCT00763841
Collaborator
NSW Schizophrenia Fellowship (Other), Rebecca Cooper Medical Research Foundation (Other)
18
1
2
108
0.2
Study Details
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 |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Sep 1, 1999
Actual Primary Completion Date
:
Sep 1, 2008
Actual Study Completion Date
:
Sep 1, 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
- Daily Voices Ratings (Mental Health Research Institute, Victoria) [Daily]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00763841
Other Study ID Numbers:
- 07019
First Posted:
Oct 1, 2008
Last Update Posted:
Jan 20, 2010
Last Verified:
Nov 1, 2009