NCT04061707

Subcutaneous EEG: Forecasting of Epileptic Seizures

Subcutaneous EEG: Forecasting of Epileptic Seizures Through Investigation of Long-term Dynamics of Seizure Occurrences, Stress, Sleep and Other Factors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Protocol Summary Population - Target population is 10 adults (18 to 75 years of age) with a diagnosis of treatment-resistant epilepsy with at least 20 seizures per year, and whose seizure onset recorded from scalp EEG is localized to a brain region accessible by the subcutaneous EEG electrodes Number of sites - Three sites; King's College Hospital NHS Foundation Trust, University College London Hospital NHS Foundation Trust, St George's University Hospital NHS Foundation Trust Study design - This study is an observational, non-randomised, non-interventional study. It is not intended as a device trial. It is not intended to assess the device performance, rather the usefulness of bio-signals in seizure prediction and in detecting seizure-associated phenomena. There will be no change to usual care as a result of taking part. A subcutaneous EEG device will be implanted under local anaesthesia to record continuous EEG and a non-invasive wrist-worn sensor will be used to acquire non-EEG bio-signals (eg. heart activity and rate, movements, muscle activity, electrodermal activity, body temperature) Objectives - The association will be investigated between non-invasive measurable variables related to stress and sleep, semi-invasive subcutaneous EEG phenomena, and the occurrence of seizures. The predictive value of change in non-invasive variables semi-invasive subcutaneous EEG phenomena for the occurrence of seizures will be assessed. Study Duration - Up to one year for each patient. Participants may be approached during or after this study to participate in related studies. Funding - This study receives funding from the Epilepsy Foundation of America, Innovative Medicines Institute (IMI) and UNEEG medical A/S.

Conditions

• Epilepsies, Focal

Timeline

• Start date: 2019-05-15
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2019-08-20
• Last updated: 2023-10-27

Locations

1 site across 1 country: United Kingdom