EpilepsyREAL-ASENCT06144047
Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
A study testing EEG SubQ subcutaneous EEG device in people with Epilepsy, run by King's College London at 1 site in United Kingdom.
Trial summary
The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- EEG SubQ subcutaneous EEG device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2023to 30 Sep 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent
- Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes.
- Adults (≥18 years of age)
- Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study.
- Experiencing ≥10 seizures per year according to their existing seizure diary.
- Willing and able to comply with study procedures
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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London
Eren Dursun, eren.dursun@kcl.ac.uk
About this study
Official title: Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.
- Conditions
- Epilepsy
- Being tested
- EEG SubQ subcutaneous EEG device
- Keywords
- epilepsy, EEG, subcutaneous EEG, mobile devices, wearable devices
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG SubQ subcutaneous EEG deviceDevice
2-channel subcutaneous EEG device
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Other | 33 participants with drug-resistant epilepsy will be implanted with the EEGTM SubQ device under local anaesthesia, and will collect 2-channel EEG data, as well as completing an electronic seizure diary, for 6 months Receives: Device: EEG SubQ subcutaneous EEG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
Within-participant correlation between seizure counts per month estimated from rapid review of annotated 24/7 EEG™ SubQ data and 'ground truth' EEG seizure occurrences per month
Measured: 6 months
Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary
Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month
Measured: 6 months
Clinician rating of accuracy of 24/7 EEG SubQ
Clinician rating of accuracy of 24/7 EEG SubQ solution
Measured: 6 months
Secondary outcomes (17)
Clinical relevance of the 24/7 EEG SubQ solution
Change over time for average Health Care Professional (HCP) questionnaires 'Communication', 'Insight' \& 'Potential of 24/7 EEG™' scores
Measured: baseline, 2 months and 6 months
Proportion of treating clinicians changing clinical management
Proportion of treating clinicians changing clinical management throughout the study due to information from the 24/7 EEG SubQ Solution
Measured: months 1, 2, 3, 4, 5, 6
Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ
Participants overall rating of the value of receiving feedback about seizures occurrences every month, across the full study period, from the EEG data recorded with 24/7 EEG™ SubQ
Measured: 6 months
participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution
Post-market surveillance questionnaire
Measured: baseline, 2 months and 6 months
Participant adherence with 24/7 EEG™ SubQ Solution
Wear time
Measured: 6 months
Device deficiency
Number of Device deficiencies
Measured: 6 months
EQ-5D-5L score
Change over time for average EQ-5D-5L scores at baseline, 2- months and 6 months
Measured: baseline, 2 months and 6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score
Change over time for average Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) scores at baseline, 2-months and 6 months
Measured: baseline, 2 months and 6 months
Impact of epilepsy score
Change over time for average Impact of epilepsy score at baseline, 2-months and 6 months
Measured: baseline, 2 months and 6 months
Perceived Self-Mastery Over Epilepsy score
Change over time for average Perceived Self-Mastery Over Epilepsy score at baseline, 2-months and 6 months
Measured: baseline, 2 months and 6 months
health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution
Client Services Receipt Inventory (CSRI) scores at 6 months
Measured: 6 months
health economic impact of epilepsy for participants compared to historical controls
Client Services Receipt Inventory (CSRI) score at 6 months compared with the 138 participants in SMILE study in the treatment-as-usual arm
Measured: 6 months
Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution
Quality-adjusted life-years (QALYs) score
Measured: 6 months
EQ-5D-5L score comparison with historical controls
EQ-5D-5L score compared with the 138 participants in SMILE study in the treatment-as-usual arm
Measured: 6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score compared with the 138 participants in SMILE study in the treatment-as-usual arm
Measured: 6 months
Impact of epilepsy score comparison with historical controls
Impact of epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
Measured: 6 months
Perceived Self-Mastery Over Epilepsy score comparison with historical controls
Perceived Self-Mastery Over Epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start18 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
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, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144047
- Sponsor's protocol ID
- IRAS: 324630
- Acronym
- REAL-ASE
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
- ClinicalTrials.gov ID
- NCT06144047
- Acronym / sponsor ID
- REAL-ASE / IRAS: 324630
- Conditions
- Epilepsy
- Keywords
- epilepsy, EEG, subcutaneous EEG, mobile devices, wearable devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Nov 2023 (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.
The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Other | Device: EEG SubQ subcutaneous EEG device33 participants with drug-resistant epilepsy will be implanted with the EEGTM SubQ device under local anaesthesia, and will collect 2-channel EEG data, as well as completing an electronic seizure diary, for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have given written informed consent
- Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes.
- Adults (≥18 years of age)
- Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study.
- Experiencing ≥10 seizures per year according to their existing seizure diary.
Key exclusion criteria (2 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG SubQ subcutaneous EEG device2-channel subcutaneous EEG device | Device | Epilepsy |
Primary outcome
Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
Time frame: 6 months
Within-participant correlation between seizure counts per month estimated from rapid review of annotated 24/7 EEG™ SubQ data and 'ground truth' EEG seizure occurrences per month
Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary
Time frame: 6 months
Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month
Clinician rating of accuracy of 24/7 EEG SubQ
Time frame: 6 months
Clinician rating of accuracy of 24/7 EEG SubQ solution
17 secondary outcomes
Clinical relevance of the 24/7 EEG SubQ solution
Time frame: baseline, 2 months and 6 months
Proportion of treating clinicians changing clinical management
Time frame: months 1, 2, 3, 4, 5, 6
Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ
Time frame: 6 months
participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution
Time frame: baseline, 2 months and 6 months
Participant adherence with 24/7 EEG™ SubQ Solution
Time frame: 6 months
Device deficiency
Time frame: 6 months
EQ-5D-5L score
Time frame: baseline, 2 months and 6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score
Time frame: baseline, 2 months and 6 months
Impact of epilepsy score
Time frame: baseline, 2 months and 6 months
Perceived Self-Mastery Over Epilepsy score
Time frame: baseline, 2 months and 6 months
health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution
Time frame: 6 months
health economic impact of epilepsy for participants compared to historical controls
Time frame: 6 months
Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution
Time frame: 6 months
EQ-5D-5L score comparison with historical controls
Time frame: 6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls
Time frame: 6 months
Impact of epilepsy score comparison with historical controls
Time frame: 6 months
Perceived Self-Mastery Over Epilepsy score comparison with historical controls
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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 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?
A study testing EEG SubQ subcutaneous EEG device in people with Epilepsy, 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eren Dursun (+44 (0)20 7836 5454, eren.dursun@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution (time frame: 6 months). The study lists 3 primary outcomes in all. 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 22 Nov 2023.