Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

Not Applicable

Completed

• Conditions: Healthy; Autoimmune Epilepsy
• Interventions: Device: Biosensor

• Registration Number: NCT05627661
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-27
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-25
• Primary Completion: 2023-11-22
• Study Completion: 2023-11-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients diagnosed with or suspected of having autoimmune epilepsy.
• Normal controls - cognitively normal subjects without epilepsy

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls with Biosensors	Biosensor	Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.
Autoimmune Epilepsy with Biosensors	Biosensor	Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.

Primary Outcome Measures

Name	Time	Method
Number of high-quality physiological signals	10 days	Total number of high-quality physiological signals recorded by biosensors
Number of Reproducible changes in physiological biosignals	10 days	Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States