Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

NCT05627661 | Completed

• 1 other identifier: 22-006702
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Epilepsy; Healthy

Outcome Measures

Primary Outcomes (2)

• Number of high-quality physiological signals

  Total number of high-quality physiological signals recorded by biosensors

  10 days

• Number of Reproducible changes in physiological biosignals

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

  10 days

Study Arms (2)

Autoimmune Epilepsy with Biosensors

EXPERIMENTAL

Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.

Device: Biosensor

Healthy Controls with Biosensors

ACTIVE COMPARATOR

Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.

Device: Biosensor

Interventions

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

Autoimmune Epilepsy with Biosensors; Healthy Controls with Biosensors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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 Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Biosensing Techniques

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques

Study Officials

• Benjamin Brinkmann, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 25, 2022
• Study Start: October 27, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)