Development of a Practical, Minimally Invasive Seizure Gauge

NCT03745118 | Completed

• 1 other identifier: 18-008357
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

Seizure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Monitoring Device

OTHER

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

Device: EpiTel EpiLog; Device: Byte Flies Sensor Dots; Device: Empatica E4; Device: Biovotion Everion; Device: GeneActiv

Interventions

EpiTel EpiLog DEVICE

Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel

Also known as: Epilog

Monitoring Device

Byte Flies Sensor Dots DEVICE

Plastic pads that will be adhered to your chest area

Also known as: Byteflies, Sensor Dots

Monitoring Device

Empatica E4 DEVICE

wearable seizure detection wristband

Also known as: E4 Wristband

Monitoring Device

Biovotion Everion DEVICE

wearable seizure detection device armband that is attached to upper arm

Monitoring Device

GeneActiv DEVICE

wearable seizure detection watch

Monitoring Device

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin (Ben) H. Brinkmann, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: November 19, 2018
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (1)