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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00763841




Registration number
NCT00763841
Ethics application status
Date submitted
30/09/2008
Date registered
1/10/2008
Date last updated
20/01/2010

Titles & IDs
Public title
Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations
Scientific title
A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations
Secondary ID [1] 0 0
07019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auditory Hallucinations 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial magnetic stimulation
Treatment: Devices - Sham

Experimental: 1 - Stimulation will be given daily at a particular site for three days a week

Sham Comparator: 2 -


Treatment: Devices: Transcranial magnetic stimulation
Stimulation will be given daily at a particular site for three days a week

Treatment: Devices: Sham
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily Voices Ratings (Mental Health Research Institute, Victoria)
Timepoint [1] 0 0
Daily

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Psychiatry - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NSW Schizophrenia Fellowship
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Rebecca Cooper Medical Research Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00763841
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MBBS, FRANZCP. MD
Address 0 0
University of NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00763841