Trial document




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  DRKS00005652

Trial Description

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Title

Evaluation of an EEG system with dry electrodes and wireless links (MYND) compared to a conventional EEG recorder

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Trial Acronym

MYND

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URL of the Trial

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Brief Summary in Lay Language


A novel EEG device, which operates with dry electrodes and wireless transmission is to be compared in terms of technical quality and ease of handling with a conventional EEG system.
At each subject will be carry out a fixed order of the measurement: 1. new device following by 2. conventional device.

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Brief Summary in Scientific Language

As a consequence of demographic change , the proportion of older people in the total population increases. Thus , inter alia, increases and the absolute frequency of neurological diseases . At the same time is already evident in particular in the new federal states , the trend of thinning of hospital locations , so that the need for alternative medical care approaches is . Currently it is the medical patient monitoring in domesticity ( , Home Monitoring ' (HM) ) with telemetric transmission of the results discussed in distant hospitals ( see, for example , the BMBF -funded TASC concept at the University of Magdeburg ).
The electroencephalogram (EEG ), i.e., electrical , measured at the head surface activity of the brain , is the standard clinical method of assessing the global brain function. Currently available EEG devices can only by specifically trained medical technical assistant (MTA ) will operate and own not because only by means of mechanical skin preparation and use of special gel sufficiently low electrode impedances are obtained for a HM . Furthermore, the patients are confined spatially because of the wired signal transmission to the stationary EEG machine .

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Organizational Data

  •   DRKS00005652
  •   2014/01/22
  •   [---]*
  •   yes
  •   Approved
  •   102/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1152-3485 
  •   CIV-13-06-011432 
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Health Condition or Problem studied

  •   F06.7 -  Mild cognitive disorder
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Interventions/Observational Groups

  •   20 patients with mild cognitive impairment:
    For each subject, measurement will be done at first with the new device (with dry electrodes and wireless links (MYND e1020x)) and then with the conventional EEG device (Firma Walter Graphtek PL230) in this fixed order.
  •   20 healthy subjects:
    For each subject, measurement will be done at first with the new device (with dry electrodes and wireless links (MYND e1020x)) and then with the conventional EEG device (Firma Walter Graphtek PL230) in this fixed order
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   IIa
  •   N/A
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Primary Outcome

If the technical signal quality sufficient for
the quantitative assessment of the spontaneous EEG and event-related potentials?
Is the technical signal quality in the clinically relevant range comparable to a conventional EEG machine?

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Secondary Outcome

The suitability of the new EEG machine in terms of handling for home monitoring?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/03
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

• Age> 18 years
• capacity to consent
- patients with MCI
- healthy persons

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Exclusion Criteria

Patients with MCI:
• tremor
Infectious disease
Known epilepsy
Patients who are not in a position to cope Study Procedure without the caregiver

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Otto-von-Guericke Universität MagdeburgMedizinische Fakultät
    • Mr.  Prof. Dr. med.  Hermann-Josef  Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Leibnitz Institut für Neurowissenschaften
    • Mr.  Prof. Dr. Ing.  Hermann  Hinrichs 
    • Brenneckestr. 6
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum AöRKlinik für Neurologie
    • Ms.  Anne Katrin  Baum 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Firma Nielsen
    • Insterburger Str. 16w
    • 60487  Frankfurt/Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.