Subcutaneous EEG in Epilepsy - Proof of Concept and Clinical Applications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporal Lobe Epilepsy
- Sponsor
- Zealand University Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study is a two-phase study, which aims to explore the uses of a novel electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous implantation with long-term monitoring in mind.
Detailed Description
The problem of unrecognized seizures is common for certain types of epilepsy. Electroencephalography (EEG) is an excellent method for seizure identification and recognition, but until now, it has not been feasible to perform EEG recordings for more than a few days outside a hospital or laboratory. A novel device has been developed, which might remedy that. The device is a EEG-electrode for subcutaneous implantation connected to an external data storage device. The investigators in this study hypothesize that this device might be a useful tool for ultra-long-term epilepsy monitoring. The study aims to investigate that. While the device might be used to diagnose epilepsy, it is more likely to be a good seizure counting tool and that is what the study aims to determine. Subjects include patients with mesial temporal lobe epilepsy and high seizure frequency. These will have the device implanted. Study phase 1 is a proof of concept to determine whether the device is actually able to detect epileptic seizures. This will take place during admission and be performed as simultaneous recordings with ordinary scalp EEG and the investigational device. Study phase 2 is a home monitoring to prove that devices actually provides clinically useful information regarding seizures in an outpatient setting. The study requires 9 visits from each subject over the course of 4-6 months. The investigational device will be explanted after approximately 75 days of wear.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Semiology of some seizures compatible with mesial temporal lobe involvement.
- •Paraclinical findings supporting mesial temporal seizure focus. Such proof may consist of:
- •previous EEG recording interpreted as compatible with mesial temporal involvement OR
- •radiological findings demonstrating pathology in the mesial temporal area (CT, MRI, FDG-PET or SPECT).
- •Current seizure frequency (fulfilling criteria 1) of more than one per week to be eligible to EMU admission or 1 per month for direct enrollment to home monitoring (by own account).
- •Available for the duration of the study (6 months from screening).
Exclusion Criteria
- •Known disorder of hemostasis.
- •Daily or frequent (more than 2 days per week) treatment with any drugs of the following types:
- •antiplatelets
- •anticoagulants
- •chemotherapeutics
- •non-steroid anti-inflammatory drugs (NSAID)
- •omega 3 fatty acids (fish oil)
- •Skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
- •Scheduled facial or cranial surgery within 6 months from enrollment.
- •Active deep brain stimulation device.
Outcomes
Primary Outcomes
Adverse events
Time Frame: 24 months
Descriptive account of device related adverse events
Compliance
Time Frame: 24 months
Descriptive account of compliance in use of the investigational device
Seizure comparison
Time Frame: 24 months
Qualitative comparison of patient-recorded seizures and EEGgraphical seizures