search
Back to results

Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Paired Pulse
Paired Pulse
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Transcranial Magnetic Stimulation, Paired Pulse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

True Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Arm Description

True treatment with TMS over the temporoparietal cortex.

Sham treatment with rTMS over the temporoparietal cortex.

Outcomes

Primary Outcome Measures

Hoffman Auditory Hallucination Scale
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)

Full Information

First Posted
September 13, 2005
Last Updated
July 27, 2011
Sponsor
St. Joseph's Healthcare Hamilton
search

1. Study Identification

Unique Protocol Identification Number
NCT00186771
Brief Title
Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Official Title
Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Transcranial Magnetic Stimulation, Paired Pulse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
True Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
True treatment with TMS over the temporoparietal cortex.
Arm Title
Sham Transcranial Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
Sham treatment with rTMS over the temporoparietal cortex.
Intervention Type
Device
Intervention Name(s)
Paired Pulse
Other Intervention Name(s)
TMS
Intervention Description
True treatment with rTMS over the temporoparietal cortex.
Intervention Type
Device
Intervention Name(s)
Paired Pulse
Other Intervention Name(s)
TMS
Intervention Description
Sham treatment with rTMS over the temporoparietal cortex.
Primary Outcome Measure Information:
Title
Hoffman Auditory Hallucination Scale
Description
A series of 7 questions to identify the intensity and severity of the hallucinations
Time Frame
weekly
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Marie Mueller, RN
Phone
905-522-1155
Ext
36629
Email
rmueller@stjoes.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Chalmers, RN
Phone
905-522-1155
Ext
35442
Email
schalmer@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hasey, MD
Organizational Affiliation
St. Joseph's Health Care London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Hasey, MD
First Name & Middle Initial & Last Name & Degree
Mohammad Warsi, MD
Facility Name
St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

We'll reach out to this number within 24 hrs