NCT00169689

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

First QC Date

September 9, 2005

Last Update Submit

January 28, 2008

Conditions

Schizophrenia

Keywords

schizophrenia, rTMS

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression;

    November 2007

Secondary Outcomes (1)

  • Global psychosocial functioning (GAF), PANSS-Negative Subscale,changes in EEG, heart rate variability, cortisol daytime profile, catecholamines, cognitive functioning

    November 2007

Study Arms (1)

rTMS

SHAM COMPARATOR

sham coil system versus verum rTMS stimulation

Procedure: rTMS, "repetitive transcranial magnetic stimulation"Other: rTMS

Interventions

rTMS, "repetitive transcranial magnetic stimulation"PROCEDURE

10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex

rTMS
rTMSOTHER

repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks

rTMS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV criteria for schizophrenia
  • age between 18 and 60
  • informed consent
  • right handed patient
  • no change of antipsychotic treatment \> 2 weeks before recruitment

You may not qualify if:

  • seizures, epilepsy
  • history of severe head injury
  • status post implantation of a cardiac pacemaker or other electronic devi-ses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joachim Cordes

Düsseldorf, Rhineland, 40629, Germany

Location

Related Publications (3)

  • 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.

    RESULT

  • 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.

    PMID: 24857264DERIVED

  • 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.

    PMID: 20378181DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Study Completion

August 1, 2007

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

DE(1)