Repetitive Transcranial Magnetic Stimulation - Full Text View

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00169689

Purpose

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

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

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia

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
rTMS: Sham Comparator 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, Rhineland
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 of Results:

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.

Responsible Party:	Heinrich-Heine University ( Cordes, Joachim )
Study ID Numbers:	TMS_S_01, TMS_01
Study First Received:	September 9, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00169689
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:

schizophrenia, rTMS

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 13, 2009