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NCT05627661 Clinical Trial

Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

Healthy Clinical Trial

Official title:
Managing Multiple Seizure Types With Wearable Devices

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05627661
Other study ID # 22-006702
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 27, 2022
Est. completion date December 2024

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of high-quality physiological signals Total number of high-quality physiological signals recorded by biosensors 10 days
Primary 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
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