Trial document
This trial has been registered retrospectively.
DRKS00012685
Trial Description
Title
Diagnostic and therapeutic yield of a patient controlled portable EEG device with dry electrodes (Fourier One) in home-monitoring of neurological outpatients
Trial Acronym
Home
URL of the Trial
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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.
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
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00012685
- 2017/08/09
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- no
- Approved
- 25/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
Secondary IDs
- U1111-1198-4219
Health Condition or Problem studied
- portable EEG recorder in home monitoring
- disturbances of consciousness
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.
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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
Characteristics
- Interventional
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- Other
- Blinded
- investigator/therapist
- Other
- Other
- Other
- N/A
- N/A
Primary Outcome
Technical signal quality as described by amplitude and noise measures (visual evaluation only)
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).
Countries of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
Recruitment
- Actual
- 2017/05/22
- 600
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Patients in the doctors office with a medical indication to record a conventional EEG
Exclusion Criteria
patients <18 years
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-sponsorstart of 1:1-Block address contact primary-sponsor- 0391-67-13431
- 0391-67-15233
- kneu at med.ovgu.de
- http://www.med.uni-magdeburg.de/
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-contactstart of 1:1-Block address contact scientific-contact- 0391 6713431
- 0391 67215233
- kneu at med.ovgu.de
- http://www.med.uni-magdeburg.de/
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-contactstart of 1:1-Block address contact public-contact- Tel.+49 391 6713431
- Fax:+49 391 6715233
- kneu at med.ovgu.de
- http://www.med.uni-magdeburg.de/
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupportend of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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