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

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.