UMPIRE - Trial of an implantable device for continuous monitoring of epileptic seizure activity.

Focal and Generalised Epilepsy

Epileptic seizures result from abnormal electrical activity in the brain, which can be monitored by electroencephalography (EEG). EEG monitoring may improve the detection, treatment and potentially prediction of seizures, but the equipment is cumbersome and the test is time consuming. As a result, long term seizure monitoring is often impractical and seizures are often missed during routine evaluations. The UMPIRE study evaluates the safety of Minder, an experimental device, implanted under the scalp for continuous monitoring of seizure activity. Brain activity data recorded in the study will be analysed to evaluate its utility for detecting epileptic activity and seizures.

Category
Neuroscience
Trial status
Active, not recruiting
Trial phase
Medical Device Pilot Study
Early stage studies seeking initial evidence of safety and efficacy in small numbers of participants.
Registry listing
ACTRN12619001587190 Australian New Zealand Clinical Trials Registry

Trial contact details

Contact person
Delphine Lévy-Bencheton
Email
d.levybencheton@uq.edu.au

What you need to know

Who can take part?

People aged 18 to 75, diagnosed with focal or generalised epilepsy
People with a minimum of 2 seizures per month (focal or generalized epilepsy)
Female participants of childbearing potential must avoid pregnancy during the study
Not open to participants with another implanted neurostimulation device, including vagus nerve stimulation, deep brain stimulation or cochlear implants

What is involved for you?

Participants will have the Minder device surgically implanted behind one ear, with an electrode implanted under the scalp along the back of the head. Participants are given a wearable device to transmit EEG data to a mobile phone. They will also have the following procedures and tests: