Clinical trial NCT00169689: Repetitive Transcranial Magnetic Stimulation
Official title: Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia, rTMS
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Clinical Global Impression;
timeFrame: November 2007
Secondary outcomes:
measure: Global psychosocial functioning (GAF), PANSS-Negative Subscale,changes in EEG, heart rate variability, cortisol daytime profile, catecholamines, cognitive functioning
timeFrame: November 2007
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Joachim Cordes
state: Rhineland
Study officials:
affiliation: Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf,Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
name: Joachim Cordes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heinrich-Heine-University
name: PD Dr. W Wölwer
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry Herford
name: PD Dr. MW Agelink
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wolwer W, Lowe A, Brinkmeyer J, Streit M, Habakuck M, Agelink MW, Mobascher A, Gaebel W, Cordes J. Repetitive transcranial magnetic stimulation (rTMS) improves facial affect recognition in schizophrenia. Brain Stimul. 2014 Jul-Aug;7(4):559-63. doi: 10.1016/j.brs.2014.04.011. Epub 2014 May 9.
citation: Cordes J, Thunker J, Agelink MW, Arends M, Mobascher A, Wobrock T, Schneider-Axmann T, Brinkmeyer J, Mittrach M, Regenbrecht G, Wolwer W, Winterer G, Gaebel W. Effects of 10 Hz repetitive transcranial magnetic stimulation (rTMS) on clinical global impression in chronic schizophrenia. Psychiatry Res. 2010 May 15;177(1-2):32-6. doi: 10.1016/j.psychres.2009.01.014. Epub 2010 Apr 8.