Transcranial Magnetic Stimulation (TMS) for Treatment of... | NCT00763841

Studies
Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

NCT00763841

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Jan 20, 2010Estimated

Enrollment

18Estimated

Phase

Phase 1

Conditions

Auditory Hallucinations

Interventions

Transcranial magnetic stimulation
Sham

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The University of New South WalesOTHER

Collaborators

Name	Class
NSW Schizophrenia Fellowship	UNKNOWN
Rebecca Cooper Medical Research Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Stimulation will be given daily at a particular site for three days a week	Device: Transcranial magnetic stimulation
2	Sham Comparator		Device: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial magnetic stimulation	Device	Stimulation will be given daily at a particular site for three days a week	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen Loo, MBBS, FRANZCP. MD	University of NSW	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Psychiatry		Sydney	New South Wales	2031	Australia

Condition Browse Module

MeSH Terms

ID	Term
D006212	Hallucinations

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided