Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00186771
• Other study ID #: TMS-2363
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 27, 2011
• Start date: November 2004
• Est. completion date: January 2015

Study information

• Verified date: July 2011
• Source: St. Joseph's Healthcare Hamilton
• Contact: Rose Marie Mueller, RN
• Phone: 905-522-1155
• Email: rmueller[@]stjoes.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

Device:
• Paired Pulse
True treatment with rTMS over the temporoparietal cortex.
• Paired Pulse
Sham treatment with rTMS over the temporoparietal cortex.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street	Hamilton	Ontario
Canada	St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hoffman Auditory Hallucination Scale	A series of 7 questions to identify the intensity and severity of the hallucinations	weekly	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)		2 weeks	No