ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00186771
Recruitment Status : Unknown
Verified July 2011 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : July 28, 2011
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton

Brief 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. 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 or disease Intervention/treatment Phase
Schizophrenia Device: Paired Pulse Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia
Study Start Date : November 2004
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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 Name: TMS

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 Name: TMS




Primary Outcome Measures :
  1. Hoffman Auditory Hallucination Scale [ Time Frame: weekly ]
    A series of 7 questions to identify the intensity and severity of the hallucinations


Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Gary Hasey, Director, TMS Laboratory, McMAster University
ClinicalTrials.gov Identifier: NCT00186771     History of Changes
Other Study ID Numbers: TMS-2363
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by St. Joseph's Healthcare Hamilton:
Transcranial Magnetic Stimulation
Paired Pulse

Additional relevant MeSH terms:
Schizophrenia
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms