Development of a Practical, Minimally Invasive Seizure Gauge

Epilepsy Clinical Trial

Official title:

Development of a Practical, Minimally Invasive Seizure Gauge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745118
• Other study ID #: 18-008357
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: August 5, 2022

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers are trying to assess changes in physiological signals before and during seizures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Device:
• EpiTel EpiLog
Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel
• Byte Flies Sensor Dots
Plastic pads that will be adhered to your chest area
• Empatica E4
wearable seizure detection wristband
• Biovotion Everion
wearable seizure detection device armband that is attached to upper arm
• GeneActiv
wearable seizure detection watch

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-10 days approximately
Primary	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.	2-10 days approximately

External Links

•   Epilepsy Foundation My Seizure Gauge Challenge
•   Mayo Clinic Clinical Trials