DigitalEPI - A Prospective Pilot Study

NCT05739669 | Terminated

• 1 other identifier: DigitalEPI_Brainhero_CIP_002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• % of good quality EEG recordings taken by specialised staff in a clinic with "Atlas with dry electrodes"

  The routine wet-electrode EEG recorded during study visit 1 will be compared to the EEG recorded with the portable dry-electrode EEG system (investigational device). A visual analysis based on the percentage of artifact-contaminated EEG segments and the signal-to-noise ratios (according to IFCN standards) will be performed and recordings graded on a 1-3 numerical ordinal semi-quantitative scale: 1. EEG is unrestrictedly usable for clinical reporting (i.e. the interpretation is not significantly compromised by technical artifacts, biological artifacts or any other technical aspect) 2. EEG is limitedly usable for clinical reporting (i.e. the artifacts cause uncertainty with respect to diagnosis or therapy, but do not prevent the rater from deriving diagnostic findings) 3. EEG is not usable for clinical reporting (i.e. a diagnostic finding could not be stated) The % of dry-electrode recordings scored with 1 or 2 (good quality) gathered by experts in the clinic will be reported.

  Initial visit in a clinic (one day)

• % of good quality EEG recordings taken by lay people at home with "Atlas with dry electrodes"

  If visit 1 dry electrode EEG is rated as unrestrictedly usable for clinical reporting or limitedly usable for clinical reporting (grade 1 or 2 on the 1-3 scale outlined at Outcome 1), all dry electrode EEG home recordings will be again scored as listed in Outcome 1 (outcome measures 1, 2 or 3), and compared to visit 1 dry electrode EEG. The % of dry-electrode recordings scored with 1 or 2 (good quality) gathered at home by non-professional users using the new dry electrode system

  14 days, at home

Secondary Outcomes (1)

• Number of participants that are diagnosed with epilepsy based on home recordings with "Atlas with dry electrodes"

  14 days, at home

Study Arms (1)

Sequential EEG Recordings with a wet electrode device a dry electrode device in multiple settings

OTHER

* 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"

Device: EEG recording with the comparator device Micromed Brain Quick; Device: EEG recording with the investigational device "Atlas with dry electrodes" clinic/specialized staff; Device: EEG recording with the investigational device "Atlas with dry electrodes" home/lay people

Interventions

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

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

Also known as: dry electrode recording at home, by lay people / self-EEG recording at home

Sequential EEG Recordings with a wet electrode device a dry electrode device in multiple settings

EEG recording with the comparator device Micromed Brain Quick DEVICE

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.

Also known as: wet electrode EEG recording

Sequential EEG Recordings with a wet electrode device a dry electrode device in multiple settings

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

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

Also known as: dry electrode recording in a clinic, by specialists

Sequential EEG Recordings with a wet electrode device a dry electrode device in multiple settings

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed epilepsy
• ≥ 1 seizure during the last year
• ≥ 1 routine EEG at the investigation center or VEM
• Age ≥ 18 years

You may not qualify if:

• History of PNES
• Inability to comply with the trial procedures
• Inability to give informed consent
• Pregnant and breastfeeding patients

Sponsors & Collaborators

• Brainhero GmbH: collaborator
• AIT Austrian Institute of Technology GmbH: collaborator
• Karl Landsteiner Institute for Clinical Epilepsy Research and Cognitive Neurology: lead

Study Sites (1)

Department of Neurology, Clinic Hietzing

Vienna, Austria, 1130, Austria

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christoph Baumgartner, MD

  Department of Neurology, KLI Clinical Epilepsy Research - Clinic Hietzing, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The quality of all the EEG recordings will be assessed by two highly qualified clinicians blinded to the recording condition and device. The diagnostic value of the home EEG monitoring will be evaluated by clinicians blinded to the patient's diagnosis.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The EEG recordings will be gathered from each patient (single group) with two devices, in two different conditions and their quality assessed according to international standards by the IFCN. 1. one EEG recording gathered with a CE-certified wet electrode device (Micromed Brain Quick; comparator device) by specialized staff in a clinician's office 2. one EEG recording gathered with the investigational device "Atlas with dry electrodes" by specialized staff, in a clinician's office, immediately after (1) 3. multiple EEG recordings gathered at home by non-specialized staff, for 14 days, using the investigational device "Atlas with dry electrodes" The study is exploratory. To further explore the diagnostic yield of recordings with the investigational device "Atlas with dry electrodes", the concordance of recorded dry electrode EEG data, semiautomatic analysis in encevis and data from the empatica EmbracePlus wrist device with established diagnoses will be investigated.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 22, 2023
• Study Start: January 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)