Subcutaneous EEG: Forecasting of Epileptic Seizures (SUBER)
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|ClinicalTrials.gov Identifier: NCT04061707|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : March 31, 2022
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Subcutaneous EEG: Forecasting of Epileptic Seizures Through Investigation of Long-term Dynamics of Seizure Occurrences, Stress, Sleep and Other Factors|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
- Seizure Occurence [ Time Frame: 1 year ]Proof-of-principle seizure-predictor based on continuously-acquired ultra-longterm subcutaneous EEG and non-invasive wearable sensor data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061707
|King's College Hospital NHS Foundation Trust|
|London, United Kingdom, SE5 9RS|
|Principal Investigator:||Mark P Richardson, BM FRCP PhD||King's College London|