Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

NCT ID: NCT05627661

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2023-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Epilepsy Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autoimmune Epilepsy with Biosensors

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

Group Type EXPERIMENTAL

Biosensor

Intervention Type 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

Healthy Controls with Biosensors

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

Group Type ACTIVE_COMPARATOR

Biosensor

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Benjamin H. Brinkmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benjamin Brinkmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-006702

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Subcutaneous EEG in Epilepsy
NCT02946151 COMPLETED NA
Earbud EEG Feasibility Study
NCT05257811 COMPLETED
Microelectrodes in Epilepsy
NCT05200455 COMPLETED NA
Localizing Epileptic Networks Using MRI and iEEG
NCT04649008 RECRUITING EARLY_PHASE1
Human Intracranial Electrophysiology
NCT05529264 RECRUITING NA