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SchizophreniaNCT00169689

Repetitive Transcranial Magnetic Stimulation

A study testing rTMS, "repetitive transcranial magnetic stimulation" and rTMS in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a prospective, randomized, double-blind sham-controlled study. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
rTMS, "repetitive transcranial magnetic stimulation" and rTMS
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteGermany
Study dates
Jun 2003to Aug 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Joachim Cordes

    Düsseldorf, Rhineland, 40629

Other trials in Germany

About this study

Official title: Therapeutic and Biological Effects of High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia

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

Read the detailed description

The principal objective of this trial is to investigate the effect of left prefrontal high frequency rTMS on negative symptoms in schizophrenia.

Conditions
Schizophrenia
Being tested
rTMS, "repetitive transcranial magnetic stimulation", rTMS
Keywords
schizophrenia, rTMS
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS, "repetitive transcranial magnetic stimulation"Procedure or surgery

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

  • rTMSOther

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

Study groups in NCT00169689
Study groupRoleWhat they receive
rTMSSham comparatorsham coil system versus verum rTMS stimulation
Receives: Procedure: rTMS, "repetitive transcranial magnetic stimulation"; Other: rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Global Impression;

    Measured: November 2007

Secondary outcomes (1)

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

    Measured: November 2007

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169689
Sponsor's protocol ID
TMS_S_01
Other IDs
TMS_01
Status last verified
Jan 2008
First submitted
9 Sep 2005
Last updated
30 Jan 2008
Results posted
No
Data monitoring committee
No

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.

  • 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.

    PubMed 24857264

  • 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.

    PubMed 20378181

Questions about this trial

What is this clinical trial studying?

A study testing rTMS, "repetitive transcranial magnetic stimulation" and rTMS in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression; (time frame: November 2007). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169689, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.

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