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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05739669). StuddyBuddy aggregates publicly available trial information.