Auditory HallucinationsPhase 1NCT00763841
Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations
A Phase 1 study testing Transcranial magnetic stimulation in people with Auditory Hallucinations, run by The University of New South Wales at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory Hallucinations
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 1999to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations
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.
- Conditions
- Auditory Hallucinations
- Being tested
- Transcranial magnetic stimulation, Sham
- Keywords
- Auditory hallucinations
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Stimulation will be given daily at a particular site for three days a week
ShamDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stimulation will be given daily at a particular site for three days a week Receives: Device: Transcranial magnetic stimulation |
| 2 | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Voices Ratings (Mental Health Research Institute, Victoria)
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 1999
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory HallucinationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- NSW Schizophrenia Fellowship, Rebecca Cooper Medical Research Foundation
- Investigators
- Colleen Loo, MBBS, FRANZCP. MD, Principal investigator, University of NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763841
- Sponsor's protocol ID
- 07019
- Status last verified
- Nov 2009
- First submitted
- 30 Sep 2008
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT00763841
- Acronym / sponsor ID
- 07019
- Conditions
- Auditory Hallucinations
- Keywords
- Auditory hallucinations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- NSW Schizophrenia Fellowship, Rebecca Cooper Medical Research Foundation
- Study start
- Sep 1999
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Transcranial magnetic stimulationStimulation will be given daily at a particular site for three days a week |
| 2 | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationStimulation will be given daily at a particular site for three days a week | Device | 1 |
| Sham | Device | 2 |
Primary outcome
Daily Voices Ratings (Mental Health Research Institute, Victoria)
Time frame: Daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
Related trials for Auditory Hallucinations
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Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
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DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
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Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
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Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Treatment Resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Loo, MBBS, FRANZCP. MD principal investigator
University of NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial magnetic stimulation in people with Auditory Hallucinations, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Voices Ratings (Mental Health Research Institute, Victoria) (time frame: Daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.