SchizophreniaPhase 4NCT00186771
Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
A Phase 4 study testing Paired Pulse in people with Schizophrenia, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
Trial summary
Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients. Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paired Pulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2004to Jan 2015
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia
- Auditory hallucinations occuring more than 5 times per day
- Adequate (6 weeks) trial of antipsychotic medication
- Including at least 1 atypical antipsychotic medication
- Medication stable for 4 weeks prior to commencement of the study
- Competent to consent
Who cannot join
- history of seizure disorder in patient or first degree relative
- recent head injury
- Acute suicidality
- Alcohol or substance abuse
- Implanted pacemaker or metal in head or neck
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
Hamilton, Ontario, L8N 3K7
Gary Hasey, MD
Mohammad Warsi, MD
- Recruiting
St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
Hamilton, Ontario, L8N 3K7
About this study
Official title: Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia
Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients.
Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. TMS is capable of inducing changes in the electrical activities of the brain in humans.
The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in schizophrenia.
Read the detailed description
We hypothesize that: True treatment with rTMS will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex.
FMRI will highlight areas of activation with auditory hallucinations distinct from the area identified by Hoffman's scalp based method.
Cortical inhibition as measured by paired pulse TMS will be increased after true TMS but not sham TMS.
- Conditions
- Schizophrenia
- Being tested
- Paired Pulse
- Keywords
- Transcranial Magnetic Stimulation, Paired Pulse
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired PulseDevice
Also called TMS
True treatment with rTMS over the temporoparietal cortex.
Paired PulseDevice
Also called TMS
Sham treatment with rTMS over the temporoparietal cortex.
| Study group | Role | What they receive |
|---|---|---|
| True Transcranial Magnetic Stimulation | Active comparator | True treatment with TMS over the temporoparietal cortex. Receives: Device: Paired Pulse |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Sham treatment with rTMS over the temporoparietal cortex. Receives: Device: Paired Pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hoffman Auditory Hallucination Scale
A series of 7 questions to identify the intensity and severity of the hallucinations
Measured: weekly
Secondary outcomes (1)
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2012 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Investigators
- Gary Hasey, MD, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186771
- Sponsor's protocol ID
- TMS-2363
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT00186771
- Acronym / sponsor ID
- TMS-2363
- Conditions
- Schizophrenia
- Keywords
- Transcranial Magnetic Stimulation, Paired Pulse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 16 Sep 2005 (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.
Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients.
Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. TMS is capable of inducing changes in the electrical activities of the brain in humans.
The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in schizophrenia.
Detailed description
We hypothesize that: True treatment with rTMS will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex.
FMRI will highlight areas of activation with auditory hallucinations distinct from the area identified by Hoffman's scalp based method.
Cortical inhibition as measured by paired pulse TMS will be increased after true TMS but not sham TMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True Transcranial Magnetic Stimulation | Active comparator | Device: Paired PulseTrue treatment with TMS over the temporoparietal cortex. |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Device: Paired PulseSham treatment with rTMS over the temporoparietal cortex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Schizophrenia
- Auditory hallucinations occuring more than 5 times per day
- Adequate (6 weeks) trial of antipsychotic medication
- Including at least 1 atypical antipsychotic medication
- Medication stable for 4 weeks prior to commencement of the study
Key exclusion criteria (6 listed)
- history of seizure disorder in patient or first degree relative
- recent head injury
- Acute suicidality
- Alcohol or substance abuse
- Implanted pacemaker or metal in head or neck
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 |
|---|---|---|
| Paired PulseAlso: TMSTrue treatment with rTMS over the temporoparietal cortex. | Device | True Transcranial Magnetic Stimulation |
| Paired PulseAlso: TMSSham treatment with rTMS over the temporoparietal cortex. | Device | Sham Transcranial Magnetic Stimulation |
Primary outcome
Hoffman Auditory Hallucination Scale
Time frame: weekly
A series of 7 questions to identify the intensity and severity of the hallucinations
1 secondary outcome
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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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.
Gary Hasey, MD principal investigator
St. Joseph's Health Care London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paired Pulse in people with Schizophrenia, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rose Marie Mueller, RN (905-522-1155 ext. 36629, rmueller@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hoffman Auditory Hallucination Scale (time frame: weekly). 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 28 Jul 2011.