Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02946151
Study type Interventional
Source Zealand University Hospital
Contact
Status Completed
Phase N/A
Start date November 2016
Completion date February 11, 2019

See also
  Status Clinical Trial Phase
Completed NCT06269822 - Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP
Completed NCT05159609 - Closed Loop Auditory Stimulus in Sleep and epilepsY N/A
Not yet recruiting NCT02590419 - Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery N/A
Completed NCT00595699 - Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy Phase 4
Recruiting NCT05609084 - Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy N/A
Completed NCT00344877 - Electrical Brain Stimulation to Reduce Epileptic Seizures N/A
Recruiting NCT03643471 - Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy
Terminated NCT00717431 - A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy Phase 3
Not yet recruiting NCT05794295 - Sleep Architecture & Intrinsic Oscillatory and Network Connectivity in Cognition and Executive Dysfunction in TLE N/A
Completed NCT02844465 - Stereotactic Laser Ablation for Temporal Lobe Epilepsy N/A
Recruiting NCT05179083 - Exercise for Brain Regeneration in Epilepsy Phase 1
Recruiting NCT05019404 - Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy N/A