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Device

24/7 EEG Monitoring for Temporal Lobe Epilepsy

N/A

Recruiting

Led By Jay Pathmanathan

Research Sponsored by UNEEG Medical A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Semiology of seizures compatible with temporal lobe involvement

Uncontrolled epileptic seizures

Must not have

Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement

Subject receives frequent (more than 2 days per week) treatment with drugs of the following types: antiplatelets, anticoagulants, chemotherapeutics, non-steroid anti-inflammatory drugs (NSAID)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the 24/7 EEG SubQ system to the gold standard for epilepsy monitoring (video-EEG in the Epilepsy Monitoring Unit) and to self-reported seizure log books.

Who is the study for?

This trial is for adults aged 18-75 with temporal lobe epilepsy who have uncontrolled seizures and evidence of temporal seizure focus. They must be scheduled for clinical monitoring within 12 weeks post-implant, able to consent, and complete all study procedures. Excluded are those at high risk of surgical complications or on frequent medication like antiplatelets or NSAIDs.

What is being tested?

The trial tests the 24/7 EEG™ SubQ system against standard video-EEG in a hospital setting and patient-reported seizure logs over a period of 12 weeks. It aims to assess safety and effectiveness in recording long-term EEG data for patients with temporal lobe epilepsy.

What are the potential side effects?

Potential side effects may include risks associated with minor surgery needed to implant the device, such as infection, bleeding, or allergic reactions to materials used. There might also be discomfort or skin irritation around the implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My seizures are related to the temporal lobe of my brain.

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I have seizures that my medication cannot control.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have bone damage or deformities where they plan to place the implant that could cause issues.

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I frequently take medication like blood thinners, chemotherapy drugs, or anti-inflammatory drugs.

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I have a health condition that increases my risk of surgery complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of seizures

Secondary study objectives

adverse event

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 24/7 EEG™ SubQ SystemExperimental Treatment1 Intervention

To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.

0 / 6Eligibility criteria met