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Repetitive Transcranial Magnetic Stimulation

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
rTMS, "repetitive transcranial magnetic stimulation"
rTMS
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, rTMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Joachim Cordes

Arms of the Study

Arm 1

Arm Type

Sham Comparator

Arm Label

rTMS

Arm Description

sham coil system versus verum rTMS stimulation

Outcomes

Primary Outcome Measures

Clinical Global Impression;

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
January 28, 2008
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT00169689
Brief Title
Repetitive Transcranial Magnetic Stimulation
Official Title
Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS
Arm Type
Sham Comparator
Arm Description
sham coil system versus verum rTMS stimulation
Intervention Type
Procedure
Intervention Name(s)
rTMS, "repetitive transcranial magnetic stimulation"
Intervention Description
10 Hz rTMS (10.000 stimuli) over left dorsolateral prefrontal cortex
Intervention Type
Other
Intervention Name(s)
rTMS
Intervention Description
repetitive transcranial magnetic stimulation, 10 Hz, 10.000 stimuli, 2 weeks
Primary Outcome Measure Information:
Title
Clinical Global Impression;
Time Frame
November 2007
Secondary Outcome Measure Information:
Title
Global psychosocial functioning (GAF), PANSS-Negative Subscale,changes in EEG, heart rate variability, cortisol daytime profile, catecholamines, cognitive functioning
Time Frame
November 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Cordes, MD
Organizational Affiliation
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf,Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PD Dr. W Wölwer
Organizational Affiliation
Heinrich-Heine-University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PD Dr. MW Agelink
Organizational Affiliation
Department of Psychiatry Herford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joachim Cordes
City
Düsseldorf
State/Province
Rhineland
ZIP/Postal Code
40629
Country
Germany

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
24857264
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.
Results Reference
derived
PubMed Identifier
20378181
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.
Results Reference
derived

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Repetitive Transcranial Magnetic Stimulation

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