Subcutaneous EEG in Epilepsy
NCT02946151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2019-05-08
Summary
The study is a two-phase study, which aims to explore the uses of a novel electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous implantation with long-term monitoring in mind.
Conditions
- Temporal Lobe Epilepsy
Interventions
- DEVICE
-
UNEEG implantable EEG electrode and data storage device
The implantable EEG electrode will be implanted subcutaneously in the relevant temporal region by a certified neurosurgeon. The EEGgraphical data recorded will be transmitted transcutaneously to the data storage device via an inductive link, providing continuous data on brain activity.
Sponsors & Collaborators
-
UNEEG Medical A/S
collaborator INDUSTRY -
Technical University of Denmark
collaborator OTHER -
Zealand University Hospital
lead OTHER
Principal Investigators
-
Troels Kjær, Professor · Zealand University Hospital
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2019-01-23
- Completion
- 2019-02-11
Countries
- Denmark
Study Locations
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