Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

July 27, 2011 updated by: St. Joseph's Healthcare Hamilton

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

Unknown

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

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: Paired Pulse
True treatment with rTMS over the temporoparietal cortex.
Other Names:
  • TMS
Device: Paired Pulse
Sham treatment with rTMS over the temporoparietal cortex.
Other Names:
  • TMS
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham treatment with rTMS over the temporoparietal cortex.
Device: Paired Pulse
True treatment with rTMS over the temporoparietal cortex.
Other Names:
  • TMS
Device: Paired Pulse
Sham treatment with rTMS over the temporoparietal cortex.
Other Names:
  • TMS

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

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Gary Hasey, MD, St. Joseph's Health Care London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 28, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS-2363

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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