Status:
UNKNOWN
Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
Lead Sponsor:
King's College London
Collaborating Sponsors:
King's College Hospital NHS Trust
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
July 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06144047
Start Date
July 18 2023
End Date
September 30 2025
Last Update
November 22 2023
Active Locations (1)
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1
King's College London
London, United Kingdom