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Wearable Biosensors for Autoimmune Epilepsy
N/A
Waitlist Available
Led By Benjamin Brinkmann, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients diagnosed with or suspected of having autoimmune epilepsy
Normal controls - cognitively normal subjects without epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
Study Summary
This trial seeks to detect physical signals that can help predict epileptic seizures, such as heart rate, muscle activity and EEG.
Who is the study for?
This trial is for individuals diagnosed with or suspected to have autoimmune epilepsy, as well as healthy people without epilepsy. Participants must be able to manage smart devices and not have open wounds near monitoring sites or cognitive conditions that would limit cooperation.Check my eligibility
What is being tested?
The study is testing wearable biosensors on patients with autoimmune epilepsy and healthy subjects. It aims to identify consistent changes in physical signals like heart rate, muscle activity, and brain waves before and during seizures.See study design
What are the potential side effects?
Since the intervention involves non-invasive wearable devices, side effects are minimal but may include discomfort from wearing the device or skin irritation at the site of wear.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with or suspected to have autoimmune epilepsy.
Select...
I do not have epilepsy and my cognitive functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Reproducible changes in physiological biosignals
Number of high-quality physiological signals
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Autoimmune Epilepsy with BiosensorsExperimental Treatment1 Intervention
Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period.
Group II: Healthy Controls with BiosensorsActive Control1 Intervention
Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,559 Total Patients Enrolled
1 Trials studying Autoimmune Epilepsy
17 Patients Enrolled for Autoimmune Epilepsy
Benjamin Brinkmann, PhDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with or suspected to have autoimmune epilepsy.You have a cognitive or psychiatric condition that makes it hard for you to use a smart watch or tablet and participate in data collection.I have open or healing wounds near areas that would be monitored.I do not have epilepsy and my cognitive functions are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Controls with Biosensors
- Group 2: Autoimmune Epilepsy with Biosensors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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