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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03745118
Other study ID # 18-008357
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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