Abstract
BackgroundThe HOMEONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield (“change of management”) of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients.MethodsThe HOMEONE study is the first step in the process of investigating whether outpatient EEG home-monitoring changes the diagnosis and treatment of patients in comparison to conventional EEG (“change of management”). Both EEG devices (conventional and portable) will be systematically compared via a two-phase intra-individual assessment.In the first phase (pilot study phase), both EEG devices will be used within neurologist practices (all other things being equal). This pilot study (involving 130 patients) will evaluate the technical usability and efficacy of the new portable dry electrode EEG recorder in comparison to conventional EEG devices. Judgements will be based on technical assessments and EEG record examinations of private practitioners and two experienced neurologists (percent of concordant readings and kappa values).The second phase (feasibility study phase) aims to assess patients’ acceptability and feasibility of the EEG home-monitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected.For this purpose, a conventional EEG will be recorded in neurologist practices. Thereafter, the practice staff will instruct the patients on how the portable EEG device functions. The patients will subsequently use the devices in their home environment.The evaluation will compare the before and after documented diagnostic findings and the therapeutic consequences of the private practitioners with those of two experienced neurologists.DiscussionTo the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the CNS or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients. If the two phases of the HOMEONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies.Trial registrationDRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.
Highlights
The HOMEONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield (“change of management”) of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients
To the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the Central nervous system (CNS) or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients
This results in new possibilities for the differential diagnosis of suspected cases of epilepsy, unclear consciousness disturbances, sleep disturbances, Attention deficit hyperactivity disorder (ADHD), or other disorders of the CNS, in contrast to other causes
Summary
The HOMEONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield (“change of management”) of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients. The second phase (feasibility study phase) aims to assess patients’ acceptability and feasibility of the EEG homemonitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected For this purpose, a conventional EEG will be recorded in neurologist practices. The use of the new EEG device might result in changes in the therapeutic management (e.g., changes in medication) These possible changes are summarized under the term “change-of-management” and reflect the therapeutic yield of a patient-controlled EEG home-monitoring. In this regard, the new portable dry electrode EEG recorder is intended to be used for both diagnostic performance and part of the therapeutic management
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
