Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
NCT ID: NCT06144047
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2023-07-18
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Epilepsy
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
EEG SubQ subcutaneous EEG device
2-channel subcutaneous EEG device
Interventions
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EEG SubQ subcutaneous EEG device
2-channel subcutaneous EEG device
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
18 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Mark P Richardson
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS: 324630
Identifier Type: -
Identifier Source: org_study_id