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Keep this study
Lead
University of Edinburgh
With
NHS Lothian
Two duplicate novel medical devices conforming to safety regulation BS EN 60601 containing the unique algorithm will be evaluated in clinical trials at two hospitals over a 14 month period. Each device is time synchronised with an Electroencephalographic (EEG) videotelemetry system which is the gold standard in identifying different seizure types recording from scalp electrodes. The devices will be monitoring participants from 3 months and older (children and adults). The algorithm was created from results from a PhD where 527 seizures were categorised into different seizure types. Sensitivity of identifying seizures was 91% and specificity was 75% using an optimal trigger level and algorithm. This trial will investigate how reliable the algorithm is in practice and determine an optimal trigger level..
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Frequent epileptic seizures 3 months and older Informed consent for participation
You may not be if
Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.
Clareo Health | Preliminary Testing of a Novel Device to Detect Epileptic Seizures