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OpenTrials
Completed

NCT Number: NCT05627661

Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

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.

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Key information

Conditions

Autoimmune Epilepsy Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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).

Treatment and study plan

Biosensor

Device

Noninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days

Primary outcomes

  1. Number of high-quality physiological signals

    Time frame: 10 days

    Total number of high-quality physiological signals recorded by biosensors

  2. Number of Reproducible changes in physiological biosignals

    Time frame: 10 days

    Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Managing Multiple Seizure Types With Wearable Devices

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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