Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012685

Trial Description

start of 1:1-Block title

Title

Diagnostic and therapeutic yield of a patient controlled portable EEG device with dry electrodes (Fourier One) in home-monitoring of neurological outpatients

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

Trial Acronym

Home

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

The examination of the diagnostic and therapeutic knowledge gained from a portable EEG recorder is compared with the conventional EEG technique used in ambulatory care in the context of a two-phase intra-individual comparison.
A portable dry electrode EEG device (Fourier One), which is integrated in a patient-friendly cap, records brain waves continuously or patient-controlled over a longer period of time, technically similar to the outpatient ECG monitoring. The patient can place the portable EEG device independently, without the help of medical staff. Therefore it can also be used in the home environment (home monitoring). This results in new possibilities for the diagnosis of epilepsies, syncope or unclear consciousness disorders, sleep disturbances, ADHD or other disorders of the CNS or the cardiovascular system. Until now, an EEG could only be recorded with considerable effort over a longer period of time under everyday conditions of the patient. It was also not possible for patients to place an EEG cap on their own.

In order to investigate the question of whether an outpatient EEG home monitoring changes the diagnosis and, as a result, the treatment of patients against the conventional EEG ("change of management"), the conventional and the portable EEG are systematically compared intra-individually. In the first phase of the study (feasibility study), both the portable EEG device and the conventional EEG are used in the practices of neurologists. In the second phase (home monitoring study), a conventional EEG is first recorded in the practices of neurologists. Afterwards the practice staff gives instructions to the patients regarding the functioning of the portable EEG device, which subsequently the patients should use independently in their home environment.
Before the use of the EEG devices, the private practitioners document the diagnostic question and the therapeutic options. After their use, they document their diagnostic findings and the therapeutic consequences. In both phases of the study, two experienced neurologists write a second report regarding their diagnostic findings of the conventional EEG and the portable EEG (blinded data) with the consent of the patient, in the University Department of Neurology Magdeburg.

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

Brief Summary in Scientific Language

We plan to evaluate the usability of a novel dry electrode multi channel EEG recording technique under the constraints of an ambulatory recording condition. In particualar, we will identify its specific benefit compared to conventional , non mobile wet electrod EEG recorders

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012685
  •   2017/08/09
  •   [---]*
  •   no
  •   Approved
  •   25/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1198-4219 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   portable EEG recorder in home monitoring
  •   disturbances of consciousness
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   In the first phase of the study (feasibility study), both the portable EEG device and the conventional EEG are used in the practices of neurologists.
  •  
    In the second phase (home monitoring study), a conventional EEG is first recorded in the practices of neurologists. Afterwards the practice staff gives instructions to the patients regarding the functioning of the portable EEG device, which subsequently the patients should use independently in their home environment.
    Clinical use per EEG 20 minutes
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Blinded
  •   investigator/therapist
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Technical signal quality as described by amplitude and noise measures (visual evaluation only)

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

Secondary Outcome

Change of management induced by the evaluation of the ambulatory EEG recording

All documentation of the practicing physicians before and after EEG will be read twice by neurologists of the university clinic (possibly diagnosis enhancement).

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

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/05/22
  •   600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients in the doctors office with a medical indication to record a conventional EEG


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

Exclusion Criteria

patients <18 years

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät Klinik für Neurologie
    • Mr.  Prof. Dr.  Hans-Jochen  Heinze 
    • Leipziger Str.44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät Klinik für Neurologie
    • Mr.  Prof. Dr.  Hans-Jochen  Heinze 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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
    • Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät Klinik für Neurologie
    • Mr.  Prof. Dr.  Hans-Jochen  Heinze 
    • Leipziger Str.44
    • 39120  Magdeburg
    • 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
    • EU - EFRE Sachsen-Anhalt Haus 5 /EU Verwaltungsbehörde
    • Dr.   Astrid   Eich-Krohm 
    • Olvenstedter Str. 4
    • 39108  Magdeburg
    • 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 ongoing
  •   [---]*
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.