Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: 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

DRKS-ID: DRKS00012685
Date of Registration in DRKS: 2017/08/09
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

Universal Trial Number (UTN): U1111-1198-4219

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

Free text: portable EEG recorder in home monitoring
Free text: disturbances of consciousness

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: 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.
Arm 2:
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

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Other
Blinding: Blinded
Who is blinded: investigator/therapist
Control: Other
Purpose: Other
Assignment: Other
Phase: N/A
Off-label Drug use: 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

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

Doctor's Practice 18 neurologische Praxen in ganz Sachsen-Anhalt

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2017/05/22
Target Sample Size: 600
Monocenter/Multicenter trial: Multicenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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
- Telephone: 0391-67-13431
- Fax: 0391-67-15233
- E-mail: kneu at med.ovgu.de
- URL: http://www.med.uni-magdeburg.de/
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
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
- Telephone: 0391 6713431
- Fax: 0391 67215233
- E-mail: kneu at med.ovgu.de
- URL: http://www.med.uni-magdeburg.de/
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
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
- Telephone: Tel.+49 391 6713431
- Fax: Fax:+49 391 6715233
- E-mail: kneu at med.ovgu.de
- URL: http://www.med.uni-magdeburg.de/
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

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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
- Telephone: [---]*
- Fax: [---]*
- E-mail: europa at stk.sachsen-anhalt.de
- URL: http://www.europa.sachsen-anhalt.de
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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.