Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by St. Joseph's Healthcare Hamilton
Sponsor:
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
  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:
  • paired pulse
  • 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 Names:
  • paired pulse
  • TMS

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
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, see Learn About Clinical Studies.

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 July 31, 2014