SeizEAR for Seizures

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Seizures, Major health conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new in-ear device called SeizEAR to determine if it can safely and effectively measure seizures compared to the usual scalp sensor method. Initially, the research involves healthy individuals to ensure the device functions correctly before testing it on those who have seizures or are suspected of having them. Ideal candidates for the trial include individuals scheduled for a clinical EEG test due to seizures or suspected temporal lobe seizures. As an unphased trial, this study allows participants to contribute to the development of innovative seizure-monitoring technology.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, medications that would interfere with EEG testing are not allowed, so it's best to discuss your current medications with the study team.

What prior data suggests that this in-ear device is safe for measuring seizures?

Research shows that the SeizEAR device, which measures seizures, is in the early testing stages to assess its safety and practicality. Currently, limited information exists about its safety in humans. The trial seeks both healthy individuals and those with seizures to test the device.

As the trial is just beginning, detailed safety information is not yet available. However, early tests are crucial to determine how well people can use the device without issues. These initial trials ensure the device's safety before wider use.

In summary, while specific safety details for SeizEAR are not yet available, these early trials are essential for understanding the device's safety and comfort for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SeizEAR because it offers a new approach to managing seizures, particularly those related to the temporal lobe. Unlike traditional treatments like anticonvulsant medications, which chemically alter brain activity, SeizEAR uses advanced EEG technology to provide real-time monitoring and potentially more precise diagnostics. This could lead to earlier and more accurate detection of seizure activity, allowing for personalized treatment plans. By giving doctors a better understanding of seizure patterns, SeizEAR aims to tailor interventions more effectively, which could improve patient outcomes significantly.

What evidence suggests that the SeizEAR device is effective for measuring seizures?

Research shows that the SeizEAR device tracks seizures using a sensor placed in the ear, unlike the usual method of attaching electrodes to the scalp to record brain activity. Although direct evidence from human studies on SeizEAR's effectiveness is not yet available, the device aims to make seizure monitoring more comfortable and easier. This trial will test the SeizEAR device in two groups: participants with seizures or suspected temporal lobe seizures, and healthy participants with no seizures. The traditional scalp-based method reliably detects seizures, so the trial will assess whether the in-ear device can match or surpass this accuracy. If successful, SeizEAR could offer a new, less intrusive way to monitor seizures, particularly benefiting those with temporal lobe epilepsy, where surgery often results in being seizure-free. ^{1 6 7 8 9}

Who Is on the Research Team?

Ho Wing (Andy) Chan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for healthy individuals and patients with seizures or suspected seizures. Initially, five healthy volunteers will be recruited from the Neurology Department to test an in-ear device. If successful, it will then be tested on ten patients scheduled for standard scalp EEG tests.

Inclusion Criteria

Normal parameters for vitals, afebrile, blood pressure

Able to read and write English

Capable of providing informed consent

Exclusion Criteria

I have been treated for an ear infection in the last month.

I have had skin sensitivity or rashes on my head, neck, or ears.

I am not on medications that would affect EEG tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Testing the in-ear device on healthy participants to assess safety and feasibility

4 weeks

1 visit (in-person)

Treatment

Testing the in-ear device on participants with seizures or suspected seizures

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SeizEAR

Trial Overview The SeizEAR Safety Study is testing a new in-ear device designed to measure seizure activity. It aims to determine if this device can safely and effectively record seizures compared to traditional scalp-based EEG monitoring methods.

How Is the Trial Designed?

Group I: Participants with seizures or suspected temporal lobe seizures Experimental Treatment 1 Intervention

Participants with seizures or suspected temporal lobe seizures scheduled for a clinical EEG.

Group II: Healthy Participants Experimental Treatment 1 Intervention

Participants with no seizures or suspected temporal lobe seizures.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07088835

Study Details | NCT07088835 | SeizEAR Safety Study Determine the safety and feasibility of an in-ear device to measure seizures or suspected seizures compared to the standard scalp-based ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12378694/

Effective Connectivity Predicts Surgical Outcomes in ... Temporal lobe epilepsy (TLE), the most common type of drug‐resistant epilepsy (DRE), has a postoperative seizure‐free rate of ~70%.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1059131107002221

Life 12 years after temporal lobe epilepsy surgery The mean follow-up of this study was 12.3 ± 0.6 years. Results showed that rates of seizure freedom were 82.5, 76.2, and 70.8% at 6 months, 2 and 12 years, ...

4. aepi.biomedcentral.com aepi.biomedcentral.com/articles/10.1186/s42494-024-00190-3

Outcome predictors in patients with temporal lobe epilepsy ... Moreover, the long-term outcome is less favorable compared to short-term outcome, with 48–58% of patients experiencing seizures five years after ...

5. neurology.org neurology.org/doi/10.1212/WNL.94.15_supplement.5271

Long-term Outcomes in Surgical Patients with Intractable ... At last follow up appointment, 86% of those who underwent a left temporal lobectomy versus 66% after a right temporal lobectomy, achieved seizure freedom, p = ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK549852/

Temporal Seizure - StatPearls - NCBI Bookshelf - NIH Temporal lobe epilepsy is the commonest seizure disorder and affects approximately fifty million people worldwide.

7. mayoclinic.org mayoclinic.org/diseases-conditions/temporal-lobe-seizure/symptoms-causes/syc-20378214

Temporal lobe seizure - Symptoms and causes Temporal lobe seizures are sometimes called focal seizures with impaired awareness. Some people are aware of what's going on during the seizure.

8. epilepsy.com epilepsy.com/what-is-epilepsy/syndromes/temporal-lobe-epilepsy

Temporal Lobe Epilepsy (TLE) Temporal lobe epilepsy is the most common form of focal epilepsy. About 6 out of 10 people with focal epilepsy have temporal lobe epilepsy.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1388245722008409

Detecting temporal lobe seizures in ultra long-term ... An overall seizure detection sensitivity of 86% was demonstrated. False detection rates were found to be a median of 2.4 false detection per 24 hours for PWE ( ...