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Not Yet Recruiting
NCT05739669
DigitalEPI - A Prospective Pilot Study
Conditions: Epilepsy
Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 18
Sponsor: Brainhero GmbH
Summary
Not all patients with epilepsy requiring advanced checkups in specialized tertiary centers can be admitted for long-term video EEG monitoring.
Home EEG recordings or home EEG monitoring using self-applicable EEG recording systems would therefore help overcome an unmet need in the treatment of such patients.
Dry electrode EEG systems are more user-friendly than wet electrode EEG systems.In this study, the quality of EEG recordings with a novel dry electrode EEG system (Atlas with dry electrodes) will be compared with the quality of recordings with a conventional wet electrode EEG system used in clinical practice.
Secondly, the quality for medical reporting of self-recorded EEG at home by patients with the dry electrode EEG system (Atlas with dry electrodes) will be compared to recordings with the same system in a clinician's office by specialized staff.
Thirdly, there will be an exploratory assessment of the value for diagnostics of EEG data from multiple home-recorded dry electrode EEGs, automatic analysis of those recordings and data from a wrist device.The patients that fulfill inclusion criteria and do not meet exclusion criteria will all undergo the following:a visit to a clinic where a health care professional will record (1) their EEG activity for 15 minutes using a CE-certified EEG device with wet electrodes; and immediately after record (2) their EEG activity for 15 minutes using the investigational EEG device "Atlas with dry electrodes"self-record their EEG activity at home, using the EEG device "Atlas with dry electrodes", at least twice per day, for 14 days; during this phase, continuous non-invasive recordings of bio signals, i.e. heart rate, muscle activity, using the Empatica EmbracePlus device will be recorded and patients will report events or findings in a paper based study diary.a last visit to the clinic to return equipment, study diary and fill in questionnaires
Eligibility Criteria
Inclusion Criteria:Diagnosed epilepsy≥ 1 seizure during the last year≥ 1 routine EEG at the investigation center or VEMAge ≥ 18 yearsExclusion Criteria:History of PNESInability to comply with the trial proceduresInability to give informed consentPregnant and breastfeeding patients
Source: ClinicalTrials.gov (NCT05739669). StuddyBuddy aggregates publicly available trial information.