Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05627661

Collaborator

(none)

Enrollment

Location

Arms

25.2

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Epilepsy Healthy	Device: Biosensor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Managing Multiple Seizure Types With Wearable Devices

Actual Study Start Date :

Oct 27, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autoimmune Epilepsy with Biosensors Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.	Device: Biosensor Noninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days
Active Comparator: Healthy Controls with Biosensors Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.	Device: Biosensor Noninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days

Arm

Intervention/Treatment

Experimental: Autoimmune Epilepsy with Biosensors

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

Device: Biosensor

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

Active Comparator: Healthy Controls with Biosensors

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

Device: Biosensor

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Benjamin Brinkmann, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Benjamin H. Brinkmann, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05627661

Other Study ID Numbers:

22-006702

First Posted:

Nov 25, 2022

Last Update Posted:

Nov 25, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Seizures

Study Results

No Results Posted as of Nov 25, 2022