Testing a new device for monitoring epilepsy seizures
Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
NA · King's College London · NCT06144047
This study is testing a new device that monitors seizures in people with epilepsy to see if it works better than keeping a diary of seizures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06144047 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a minimally-invasive subcutaneous EEG device, UNEEG™ SubQ, in accurately counting epileptic seizures compared to traditional participant-reported seizure diaries. Over six months, 33 participants with drug-resistant epilepsy will have the device implanted to collect continuous EEG data, which will be analyzed and communicated to their clinicians. The study aims to assess the feasibility and acceptability of this method, its impact on quality of life, and potential cost-effectiveness for the healthcare system.
Who should consider this trial
Good fit: Ideal candidates are adults with treatment-resistant epilepsy who experience at least 10 seizures per year and are willing to use a smartphone for an electronic seizure diary.
Not a fit: Patients with psychogenic non-epileptic attacks or those with frequent involuntary movements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate seizure monitoring and improved management of epilepsy, enhancing patients' quality of life.
How similar studies have performed: Other studies have shown promise in using wearable devices for seizure monitoring, but this specific approach with subcutaneous EEG is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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)
Where this trial is running
London
- King's College London — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Mark P Richardson — King's College London
- Study coordinator: Eren Dursun
- Email: eren.dursun@kcl.ac.uk
- Phone: +44 (0)20 7836 5454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, epilepsy, EEG, subcutaneous EEG, mobile devices, wearable devices