Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOMEONE pilot study

Thomas Neumann; Anne Katrin Baum; Ulrike Baum; Renate Deike; Helmut Feistner; Hermann Hinrichs; Joseph Stokes; Bernt-Peter Robra

doi:10.1186/s40814-018-0296-2

Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOME^ONE pilot study

Pilot Feasibility Stud. 2018 May 21:4:100. doi: 10.1186/s40814-018-0296-2. eCollection 2018.

Authors

Thomas Neumann^{1

2}, Anne Katrin Baum¹, Ulrike Baum¹, Renate Deike¹, Helmut Feistner¹, Hermann Hinrichs^{1

3

4

5}, Joseph Stokes¹, Bernt-Peter Robra⁶

Affiliations

¹ 1University Department of Neurology, Otto-von-Guericke-University Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany.
² 3Chair in Empirical Economics, Otto-von-Guericke-University Magdeburg, Universitätsplatz 2, 39106 Magdeburg, Germany.
³ 2Leibniz Institute for Neurobiology, Brenneckestraße 6, 39118 Magdeburg, Germany.
⁴ 5German Center for Neurodegenerative Diseases, Site Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany.
⁵ 6Forschungscampus STIMULATE, Otto-von-Guericke-University Magdeburg, Sandtorstraße 23, 39106 Magdeburg, Germany.
⁶ 4Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany.

Abstract

Background: The HOME^ONE 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.

Methods: The HOME^ONE 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.

Discussion: 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 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 HOME^ONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies.

Trial registration: DRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.

Keywords: Diagnostic testing; Home monitoring; Intra-individual comparison; Portable EEG.