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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014