- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186771
Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3K7
- Recruiting
- St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
-
Principal Investigator:
- Gary Hasey, MD
-
Sub-Investigator:
- Mohammad Warsi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: True Transcranial Magnetic Stimulation
True treatment with TMS over the temporoparietal cortex.
|
True treatment with rTMS over the temporoparietal cortex.
Other Names:
Sham treatment with rTMS over the temporoparietal cortex.
Other Names:
|
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham treatment with rTMS over the temporoparietal cortex.
|
True treatment with rTMS over the temporoparietal cortex.
Other Names:
Sham treatment with rTMS over the temporoparietal cortex.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hoffman Auditory Hallucination Scale
Time Frame: weekly
|
A series of 7 questions to identify the intensity and severity of the hallucinations
|
weekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary Hasey, MD, St. Joseph's Health Care London
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMS-2363
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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