Epilepsies, FocalSUBERNCT04061707
Subcutaneous EEG: Forecasting of Epileptic Seizures
An observational study of Epilepsies, Focal, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsies, Focal
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2019to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit 10 suitable people with epilepsy referred, as part of their routine conventional care, to the Epilepsy Clinics at King's College Hospital (KCH), University College London Hospital NHS Foundation Trust (National Hospital for Neurology and Neurosurgery - NHNN), or St George's University Hospital NHS Foundation Trust (SGH).
Who may be able to join
- Diagnosis of treatment-resistant epilepsy of any syndrome, in which seizures are detectable in scalp EEG with two electrodes
- Between the ages of 18 - 75
- Experiencing >20 seizures (with impaired awareness) per year according to seizure diary.
Who cannot join
- Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures)
- Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
- Inability to comply with the trial procedure, such as cognitive or behavioral problems
- Inability to give informed consent
- History or evidence of: Severe cardiac disease (including Pacemaker and ICD-unit), Myocardial infarction, angina pectoris or other ischaemic heart disease, Cardiac arrhythmia or Any other heart failure
- History or evidence of: Stroke, Transient ischaemic attack, Carotid or vertebral artery stenosis or dissection, Cerebral hemorrhage, Any other structural cerebral disease
Show all 18Show fewer
- Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Anticoagulation treatment, Immunosuppressant treatment, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
- Subjects under investigation or treatment of active cancer or cancer diagnosis within the past 5 years
- Subjects known with or suspected abuse of alcohol (defined as consumption of > 250g alcohol per week or abuse of any other neuro-active substances
- Subjects involved in therapies with medical devices that deliver electrical energy into the area around the implant.
- Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease.
- Subjects who are allergic to the local anesthetics used during implantation.
- Subjects whose safety blood measurements (full blood count, U\&E, clotting) are significantly out of range in the judgement of the CI.
- Females of childbearing potential who are pregnant or intend to become pregnant or are not using adequate contraceptive methods throughout the study (Safe anticontraceptive methods includes contraceptive pills, intrauterine device including hormone intrauterine device and sustained gestagen injection)
- Subjects who have an infection at the site of device implantation.
- Subjects who operate MRI scanners or are planned to have an MRI scan within the next year.
- Subjects with profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkeling is allowed to 5 meters of depth.
- Subjects with profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
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
Read more
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
- Keywords
- Focal Epilepsy, Longterm EEG Monitoring, Wearable Devices, mHealth, Seizure Forecasting
- Medical subject headings
- Epilepsies, Partial
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Occurence
Proof-of-principle seizure-predictor based on continuously-acquired ultra-longterm subcutaneous EEG and non-invasive wearable sensor data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start15 May 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, FocalStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Mark P Richardson, BM FRCP PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061707
- Sponsor's protocol ID
- IRAS: 252686
- Acronym
- SUBER
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2019
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous EEG: Forecasting of Epileptic Seizures Through Investigation of Long-term Dynamics of Seizure Occurrences, Stress, Sleep and Other Factors
- ClinicalTrials.gov ID
- NCT04061707
- Acronym / sponsor ID
- SUBER / IRAS: 252686
- Conditions
- Epilepsies, Focal
- Keywords
- Focal Epilepsy, Longterm EEG Monitoring, Wearable Devices, mHealth, Seizure Forecasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 10 suitable people with epilepsy referred, as part of their routine conventional care, to the Epilepsy Clinics at King's College Hospital (KCH), University College London Hospital NHS Foundation Trust (National Hospital for Neurology and Neurosurgery - NHNN), or St George's University Hospital NHS Foundation Trust (SGH).
Key inclusion criteria (3 listed)
- Diagnosis of treatment-resistant epilepsy of any syndrome, in which seizures are detectable in scalp EEG with two electrodes
- Between the ages of 18 - 75
- Experiencing >20 seizures (with impaired awareness) per year according to seizure diary.
Key exclusion criteria (18 listed)
- Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures)
- Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
- Inability to comply with the trial procedure, such as cognitive or behavioral problems
- Inability to give informed consent
- History or evidence of: Severe cardiac disease (including Pacemaker and ICD-unit), Myocardial infarction, angina pectoris or other ischaemic heart disease, Cardiac arrhythmia or Any other heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Epilepsies, Focal
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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Richardson, BM FRCP PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Focal, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Occurence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.