Repetitive Transcranial Magnetic Stimulation

January 28, 2008 updated by: Heinrich-Heine University, Duesseldorf

Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia

The study is a prospective, randomized, double-blind sham-controlled study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The principal objective of this trial is to investigate the effect of left prefrontal high frequency rTMS on negative symptoms in schizophrenia.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Germany
    • Rhineland
      • Düsseldorf, Rhineland, Germany, 40629
        • Joachim Cordes

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV criteria for schizophrenia
  • age between 18 and 60
  • informed consent
  • right handed patient
  • no change of antipsychotic treatment > 2 weeks before recruitment

Exclusion Criteria:

  • seizures, epilepsy
  • history of severe head injury
  • status post implantation of a cardiac pacemaker or other electronic devi-ses

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: rTMS
sham coil system versus verum rTMS stimulation
Procedure: rTMS, "repetitive transcranial magnetic stimulation"
10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex
Other: rTMS
repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression;
Time Frame: November 2007
November 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Global psychosocial functioning (GAF), PANSS-Negative Subscale,changes in EEG, heart rate variability, cortisol daytime profile, catecholamines, cognitive functioning
Time Frame: November 2007
November 2007

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Joachim Cordes, MD, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf,Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
  • Principal Investigator: PD Dr. W Wölwer, Heinrich-Heine-University
  • Principal Investigator: PD Dr. MW Agelink, Department of Psychiatry Herford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2003

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS_S_01
  • TMS_01

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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