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A Wireless EEG Patch for Continuous Electrographic Monitoring

NCT03583957 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2024-02-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Observational only

Device is only observational and used to record EEG.

BEHAVIORAL

Psychological and Behavioral interaction with a seizure forecasting mobile app

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

COMBINATION_PRODUCT

Seizure Alerting and Prediction System

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.

Sponsors & Collaborators

  • Epitel, Inc.

    lead INDUSTRY

  • Boston Children's Hospital

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • NYU Langone Health

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583957 on ClinicalTrials.gov