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Development of a Practical, Minimally Invasive Seizure Gauge

Primary Purpose

Epilepsy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EpiTel EpiLog
Byte Flies Sensor Dots
Empatica E4
Biovotion Everion
GeneActiv
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring Seizure

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S)
  • Pediatric subjects 7 years of age or older.

Exclusion Criteria:

  • Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
  • Presence of open or healing wounds near monitoring sites (infection risk).

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Monitoring Device

Arm Description

Subjects will be asked to wear up to 4 different noninvasive seizure detection devices including EpiTel EpiLog, Byte Flies Sensor Dots, Empatica E4, Biovotion Everion, GeneActiv

Outcomes

Primary Outcome Measures

Assessment of Physiological Signals Measurable with Wearable Sensors
We will collect physiological signals with the five wearable, noninvasive biosensors listed below in Mayo patients undergoing scalp-recorded video EEG and invasive stereotactic EEG/video monitoring as part of their clinical epilepsy evaluation. We will evaluate biosignals based on data quality and reliability, and subject comfort and ease of use.
Pattern Analysis
We will apply data mining and machine learning methods to search for patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
November 30, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03745118
Brief Title
Development of a Practical, Minimally Invasive Seizure Gauge
Official Title
Development of a Practical, Minimally Invasive Seizure Gauge
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The researchers are trying to assess changes in physiological signals before and during seizures.
Detailed Description
Subjects that are undergoing video EEG monitoring in the hospital for their epilepsy at Mayo Clinic will be consented to participate in this study for a minimum of two days and/or the duration of their hospital stay for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys. In the second year of the study patients who have implanted devices capable of recording or detecting seizures will be recruited to wear a noninvasive biosensor for multiple months. This data will be used to develop algorithms capable of detecting and/or forecasting seizures. When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitoring Device
Arm Type
Other
Arm Description
Subjects will be asked to wear up to 4 different noninvasive seizure detection devices including EpiTel EpiLog, Byte Flies Sensor Dots, Empatica E4, Biovotion Everion, GeneActiv
Intervention Type
Device
Intervention Name(s)
EpiTel EpiLog
Other Intervention Name(s)
Epilog
Intervention Description
Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel
Intervention Type
Device
Intervention Name(s)
Byte Flies Sensor Dots
Other Intervention Name(s)
Byteflies, Sensor Dots
Intervention Description
Plastic pads that will be adhered to your chest area
Intervention Type
Device
Intervention Name(s)
Empatica E4
Other Intervention Name(s)
E4 Wristband
Intervention Description
wearable seizure detection wristband
Intervention Type
Device
Intervention Name(s)
Biovotion Everion
Intervention Description
wearable seizure detection device armband that is attached to upper arm
Intervention Type
Device
Intervention Name(s)
GeneActiv
Intervention Description
wearable seizure detection watch
Primary Outcome Measure Information:
Title
Assessment of Physiological Signals Measurable with Wearable Sensors
Description
We will collect physiological signals with the five wearable, noninvasive biosensors listed below in Mayo patients undergoing scalp-recorded video EEG and invasive stereotactic EEG/video monitoring as part of their clinical epilepsy evaluation. We will evaluate biosignals based on data quality and reliability, and subject comfort and ease of use.
Time Frame
2-10 days approximately
Title
Pattern Analysis
Description
We will apply data mining and machine learning methods to search for patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring.
Time Frame
2-10 days approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S) Pediatric subjects 7 years of age or older. Exclusion Criteria: Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin (Ben) H. Brinkmann, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
URL
https://www.epilepsy.com/article/2019/10/driving-therapeutic-innovations-my-seizure-gauge-challenge
Description
Epilepsy Foundation My Seizure Gauge Challenge

Learn more about this trial

Development of a Practical, Minimally Invasive Seizure Gauge

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