NCT03583957

Brief Summary

This proposal will evaluate an individual-use, patch-type telemetry device for simplified, single-channel EEG recording from human patients along-side the traditional in hospital wired EEG.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

8 years

First QC Date

June 28, 2018

Last Update Submit

February 15, 2024

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

  • Single channel EEG coherence

    Patient events noted in wired EEG will be measured against physician identified events in single channel EEG

    Through study completion

  • Sensitivity and specificity for retrospect seizure detection

    The initial Phase of this program is the development and FDA clearance of an automated seizure detection system through a participants personal mobile device.

    Through Phase I completion, 2 years

  • Sensitivity and specificity for prospective seizure alerting

    The second Phase of this program is to create a real-time automated seizure alerting system for both a participants personal mobile device as well as a caregiver/parent's personal mobile device.

    Through study completion, 5 years

  • Sensitivity and specificity fro prospective seizure forecasting

    The final Phase of this program is to create an hourly seizure prediction system that provides the participant with a probability of having an electrographic seizure based on physiological, psychological, behavioral, and environmental input.

    Through study completion, 5 years

Study Arms (1)

Entire Study

EXPERIMENTAL

Each patient is eligible for all interventions in the study.

Device: Observational onlyBehavioral: Psychological and Behavioral interaction with a seizure forecasting mobile appCombination Product: Seizure Alerting and Prediction System

Interventions

Observational onlyDEVICE

Device is only observational and used to record EEG.

Entire Study
Psychological and Behavioral interaction with a seizure forecasting mobile appBEHAVIORAL

Participants will be interacting with a mobile app to input perceived behavioral (e.g., number of hours slept and sleepiness) and psychological (perceived stress).

Entire Study
Seizure Alerting and Prediction SystemCOMBINATION_PRODUCT

The combination of Epilog (device) and the Aura app (psychological and behavioral interaction) will be used to create a real-time seizure alerting and an hourly seizure forecasting system.

Entire Study

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of Epilepsy or other seizure disorder
  • Admitted for scheduled EEG testing with a minimum of overnight (24 hour) EEG
  • years of age through adult

You may not qualify if:

  • Known or suspected allergy to adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

New York University Langone Medical Center

New York, New York, 100160000, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 12, 2018

Study Start

May 8, 2018

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)