Epilepsies, Focal Clinical Trial
Official title:
Subcutaneous EEG: Forecasting of Epileptic Seizures Through Investigation of Long-term Dynamics of Seizure Occurrences, Stress, Sleep and Other Factors
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.
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