DigitalEPI - A Prospective Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Diagnosed epilepsy

• ≥ 1 seizure during the last year

• ≥ 1 routine EEG at the investigation center or VEM

• Age ≥ 18 years

Locations
Other Locations
Austria
Department of Neurology, Clinic Hietzing
RECRUITING
Vienna
Contact Information
Primary
Johannes Koren, MD, PhD
johannes.koren@gesundheitsverbund.at
00431801102524
Backup
Clemens Lang, MD
c.lang@gesundheitsverbund.at
00431801102505
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 18
Treatments
Other: Sequential EEG Recordings with a wet electrode device a dry electrode device in multiple settings
* one recording per patient (epilepsy), performed by specialized staff in a clinic, with a CE-certified wet electrode EEG device (Micromed Brain Quick)~* one recording per patient (epilepsy), performed by specialized staff in a clinic, with the investigational device Atlas with dry electrodes~* multiple daily recordings from patients with epilepsy, gathered by lay people for 14 days, at home, with the investigational device Atlas with dry electrodes
Related Therapeutic Areas
Sponsors
Collaborators: Brainhero GmbH, AIT Austrian Institute of Technology GmbH
Leads: Karl Landsteiner Institute for Clinical Epilepsy Research and Cognitive Neurology

This content was sourced from clinicaltrials.gov