DigitalEPI - A Prospective Pilot Study

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

Conditions

• Epilepsy

Interventions

DEVICE

EEG recording with the comparator device Micromed Brain Quick

Each patient will undergo a visit in a clinic, during which a 15 minutes long EEG trace with a CE-certified wet electrode EEG Device (Micromed Brain Quick) will be recorded by specialized staff.

DEVICE

EEG recording with the investigational device "Atlas with dry electrodes" clinic/specialized staff

During the same visit when the wet electrode EEG is recorded, the patient will be subjected to a second 15 minutes long EEG recording with the investigational device "Atlas with dry electrodes", which will be conducted by specialized staff

DEVICE

EEG recording with the investigational device "Atlas with dry electrodes" home/lay people

The patients will record their own EEGs at home daily for 14 days, using the investigational device "Atlas with dry electrodes"

Sponsors & Collaborators

• Brainhero GmbH

  collaborator INDUSTRY

• AIT Austrian Institute of Technology GmbH

  collaborator OTHER

• Karl Landsteiner Institute for Clinical Epilepsy Research and Cognitive Neurology

  lead OTHER_GOV

Principal Investigators

• Christoph Baumgartner, MD · Department of Neurology, KLI Clinical Epilepsy Research - Clinic Hietzing, Vienna, Austria

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Austria

Study Locations