Trial document




drksid header

  DRKS00003602

Trial Description

start of 1:1-Block title

Title

Comparison of the Brainstim tDCS stimulator versus the neuroconn tDCS stimulator in terms of effiency and comfort

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Brainstim versus neuroconn

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/forschung/tms/schwerpunkte/tdcs.html

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

transcranial direct current stimulation is a novel treatment option for various neurologic and psychiatric disorders. With electric stimulators, direct current is applied to the brain. In this trial, we compare the Italian Brainstim stimulator to the German neuroconn stimulator in terms of efficiency and comfort. The Trial is randomized and single-blinded. Outcome is measured by questionnaires and EEG measures.
Both stimulators are CE-certified.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

singel blinded, randomized cross-over study to compare the Brainstim and the neuroconn tDCS stimulator. Outcome measures are made by comfort rating questionnaires and LORETA EEG measures. There are four conditions: Italian versus German stimulator, both active and sham stimulation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003602
  •   2012/03/09
  •   [---]*
  •   yes
  •   Approved
  •   402-10, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   healthy volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   cephalic stimulation with the neuroconn stimulator, active condition
  •   cephalic stimulation with the neuroconn stimulator, sham condition
  •   cephalic stimulation with the brainstim stimulator, active condition
  •   cephalic stimulation with the brainstim stimulator, sham condition
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo, Active control
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

End point is the completion of four different treatment conditions for comparison of comfort and efficiency due to the single measures. Stimulations take place with a minimum 24 h interval, measures are immediately after stimulation. Each volunteer has to assess uncomfortable side effects of the stimulation with the Comfort Rating Questionnaire. Additionally EEG recording is performed at baseline before first stimulation and after each stimulation. Aim is to show similar effects of both stimulators in terms of comfortability of active and sham stimulation and the documentation of the same activation of deep brain regions by both stimulators, measured by EEG-LORETA.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/05/01
  •   15
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

healthy subjects

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

neurologic, psychiatric, internal, dermatologic disorders, obesity.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   089/5160-5511
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Psychiatrische Klinik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Ulrich  Palm 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/01/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.