Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

NCT ID: NCT00186771

Last Updated: 2011-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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True Transcranial Magnetic Stimulation

True treatment with TMS over the temporoparietal cortex.

Group Type ACTIVE_COMPARATOR

Paired Pulse

Intervention Type DEVICE

True treatment with rTMS over the temporoparietal cortex.

Sham Transcranial Magnetic Stimulation

Sham treatment with rTMS over the temporoparietal cortex.

Group Type SHAM_COMPARATOR

Paired Pulse

Intervention Type DEVICE

Sham treatment with rTMS over the temporoparietal cortex.

Interventions

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Paired Pulse

True treatment with rTMS over the temporoparietal cortex.

Intervention Type DEVICE

Paired Pulse

Sham treatment with rTMS over the temporoparietal cortex.

Intervention Type DEVICE

Other Intervention Names

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TMS TMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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McMAster University

Principal Investigators

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Gary Hasey, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care London

Locations

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St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Rose Marie Mueller, RN

Role: CONTACT

905-522-1155 ext. 36629

Sandra Chalmers, RN

Role: CONTACT

905-522-1155 ext. 35442

Other Identifiers

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TMS-2363

Identifier Type: -

Identifier Source: org_study_id

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