Evaluation of the 24/​7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

Overview

About this study

The main purpose of the study is to demonstrate the performance and safety of the 24/7 EEG™ SubQ system as a reliable ultra long-term recorder of epileptic electrographic seizures. First, by comparison to simultaneously recorded video-EEG in the epilepsy monitoring unit (gold standard). Second, by comparison to self-reported seizure log books throughout 12-52 weeks of outpatient EEG monitoring.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Subject is 18-75 years old.
* Semiology of seizures compatible with temporal lobe involvement
* Paraclinical findings supporting temporal seizure focus. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
* Uncontrolled epileptic seizures.
* Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG? SubQ implant.
* Subject is willing and able to provide written informed consent.
* Subject is able to complete all study-required procedures, assessments and follow-up.

Exclusion Criteria:

* Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
* Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:

1. antiplatelets
2. anticoagulants
3. chemotherapeutics
4. non-steroid anti-inflammatory drugs (NSAID)
* Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
* Subject has an active deep brain stimulation device.
* Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant.
* Subject has a cochlear implant(s).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/14/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gregory Worrell, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Karla Crockett

(507) 538-4880

Crockett.Karla@mayo.edu

More information

Publications

Publications are currently not available