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Repetitive Transcranial Magnetic Stimulation

This study has been completed.
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00169689
First received: September 9, 2005
Last updated: January 28, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinical Global Impression; [ Time Frame: November 2007 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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.

Additional 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
Study First Received: September 9, 2005
Last Updated: January 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013