Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
This study is currently recruiting participants.
Verified July 2011 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00186771
First received: September 13, 2005
Last updated: July 27, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Device: Paired Pulse |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia |
Resource links provided by NLM:
Further study details as provided by St. Joseph's Healthcare Hamilton:
Primary Outcome Measures:
- Hoffman Auditory Hallucination Scale [ Time Frame: weekly ] [ Designated as safety issue: No ]A series of 7 questions to identify the intensity and severity of the hallucinations
Secondary Outcome Measures:
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: True Transcranial Magnetic Stimulation
True treatment with TMS over the temporoparietal cortex.
|
Device: Paired Pulse
True treatment with rTMS over the temporoparietal cortex.
Other Names:
|
|
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham treatment with rTMS over the temporoparietal cortex.
|
Device: Paired Pulse
Sham treatment with rTMS over the temporoparietal cortex.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186771
Contacts
| Contact: Rose Marie Mueller, RN | 905-522-1155 ext 36629 | rmueller@stjoes.ca |
| Contact: Sandra Chalmers, RN | 905-522-1155 ext 35442 | schalmer@stjoes.ca |
Locations
| Canada, Ontario | |
| St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street | Recruiting |
| Hamilton, Ontario, Canada, L8N 3K7 | |
| Principal Investigator: Gary Hasey, MD | |
| Sub-Investigator: Mohammad Warsi, MD | |
| St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street | Recruiting |
| Hamilton, Ontario, Canada, L8N 3K7 | |
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
| Principal Investigator: | Gary Hasey, MD | St. Joseph's Health Care London |
More Information
No publications provided
| Responsible Party: | Dr. Gary Hasey, Director, TMS Laboratory, McMAster University |
| ClinicalTrials.gov Identifier: | NCT00186771 History of Changes |
| Other Study ID Numbers: | TMS-2363 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 27, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Joseph's Healthcare Hamilton:
|
Transcranial Magnetic Stimulation Paired Pulse |
Additional relevant MeSH terms:
|
Hallucinations Schizophrenia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013