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Repetitive Transcranial Magnetic Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169689
First Posted: September 15, 2005
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heinrich-Heine University, Duesseldorf
  Purpose
The study is a prospective, randomized, double-blind sham-controlled study.

Condition Intervention
Schizophrenia Procedure: rTMS, "repetitive transcranial magnetic stimulation" Other: rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Clinical Global Impression; [ Time Frame: November 2007 ]

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

Enrollment: 40
Study Start Date: June 2003
Study Completion Date: August 2007
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169689


Locations
Germany
Joachim Cordes
Düsseldorf, Rhineland, Germany, 40629
Sponsors and Collaborators
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
  More Information

Publications:
Cordes J, Arends M, Mobascher A, Jänner M, Wölwer W, Krieger K, Agelink MW, Klimke A, Brinkmeyer J. Left prefrontal high frequency repetitive transcra-nial magnetic stimulation (rTMS) and the effect on schizophrenic psychopathol-ogy. European Archives of Psychiatry and Clinical Neuroscience 2004; Vol. 254, Suppl. 1: 11. Cordes J, Brinkmeyer J, Kotrotsios G, Arends M, Mobascher A, Agelink MW, Wölwer W. The effect of high frequency repetitive transcranial magnetic stimula-tion (rTMS) on negative symptoms and electrophysiological correlates of facial affect recognition in schizophrenia. Schizophrenia Bulletin 2005 b; 31 (2): 510.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cordes, Joachim, Heinrich-Heine University
ClinicalTrials.gov Identifier: NCT00169689     History of Changes
Other Study ID Numbers: TMS_S_01
TMS_01
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Heinrich-Heine University, Duesseldorf:
schizophrenia, rTMS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders