NCT00186771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

7.2 years

First QC Date

September 13, 2005

Last Update Submit

July 27, 2011

Conditions

Keywords

Transcranial Magnetic StimulationPaired Pulse

Outcome Measures

Primary Outcomes (1)

  • Hoffman Auditory Hallucination Scale

    A series of 7 questions to identify the intensity and severity of the hallucinations

    weekly

Secondary Outcomes (1)

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

    2 weeks

Study Arms (2)

True Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

True treatment with TMS over the temporoparietal cortex.

Device: Paired Pulse

Sham Transcranial Magnetic Stimulation

SHAM COMPARATOR

Sham treatment with rTMS over the temporoparietal cortex.

Device: Paired Pulse

Interventions

True treatment with rTMS over the temporoparietal cortex.

Also known as: TMS
True Transcranial Magnetic Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Hamilton, Ontario, L8N 3K7, Canada

RECRUITING

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

Hamilton, Ontario, L8N 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Gary Hasey, MD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Marie Mueller, RN

CONTACT

Sandra Chalmers, RN

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2012

Study Completion

January 1, 2015

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations