Subcutaneous EEG: Forecasting of Epileptic Seizures (SUBER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04061707|
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : September 2, 2020
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|
|Estimated Enrollment :||10 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 :||May 15, 2021|
|Estimated Study Completion Date :||May 15, 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
|Contact: Mark P Richardson, BM FRCP PhD||+44203 299 firstname.lastname@example.org|
|Contact: Pedro F Viana, MDemail@example.com|
|King's College Hospital NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE5 9RS|
|Contact: Mark P Richardson, MD PhD +44203 299 8352|
|Contact: Pedro F Viana, MD +44203 299 8352 firstname.lastname@example.org|
|Principal Investigator:||Mark P Richardson, BM FRCP PhD||King's College London|