Back to resultsWearable Devices to Monitor Seizures in Autoimmune Epilepsy
Primary Purpose
Autoimmune Epilepsy, Healthy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biosensor
Sponsored by
About this trial
This is an interventional basic science trial for Autoimmune Epilepsy
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Autoimmune Epilepsy with Biosensors
Healthy Controls with Biosensors
Arm Description
Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.
Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.
Outcomes
Primary Outcome Measures
Number of high-quality physiological signals
Total number of high-quality physiological signals recorded by biosensors
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627661
Brief Title
Wearable Devices to Monitor Seizures in Autoimmune Epilepsy
Official Title
Managing Multiple Seizure Types With Wearable Devices
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Epilepsy, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autoimmune Epilepsy with Biosensors
Arm Type
Experimental
Arm Description
Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.
Arm Title
Healthy Controls with Biosensors
Arm Type
Active Comparator
Arm Description
Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.
Intervention Type
Device
Intervention Name(s)
Biosensor
Intervention Description
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 Outcome Measure Information:
Title
Number of high-quality physiological signals
Description
Total number of high-quality physiological signals recorded by biosensors
Time Frame
10 days
Title
Number of Reproducible changes in physiological biosignals
Description
Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Brinkmann, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Wearable Devices to Monitor Seizures in Autoimmune Epilepsy
We'll reach out to this number within 24 hrs