None listed
Conditions
Brief summary
The research project is to test and validate a new system for monitoring focal or generalised epilepsy. The new monitoring system is called Minder and is comprised of an implanted device that communicates to an external device, mobile phone and secure cloud. These components, known as the Minder system, will record each subject's electroencephalogram (EEG) data, also known as brain waves, and export it to a secure cloud via the mobile phone. The subjects will be required to use this Minder system continuously throughout the study for a period of 6 months with an optional long-term follow-up up to 3 years post-implant, during both wake and sleep. The subjects continuous EEG recordings during the study will be downloaded from the secure cloud and reviewed by trained clinical staff to detect seizures.
Interventions
Epileptic seizures recorded by a sub-scalp EEG monitor over 6 months.
The Minder system (an investigational device) includes the following components:
-An implanted electrode lead (IEL) and an implant telemetry unit (ITU) – called the Minder Implant that records two channels of EEG activity from the IEL positioned under the scalp.
-An external behind the ear (BTE) processor – called the Minder BTE that can communicate to a nearby paired mobile phone.
-A custom mobile phone application – called
Epileptic seizures recorded by a sub-scalp EEG monitor over 6 months. The Minder system (an investigational device) includes the following components: -An implanted electrode lead (IEL) and an implant telemetry unit (ITU) – called the Minder Implant that records two channels of EEG activity from the IEL positioned under the scalp. -An external behind the ear (BTE) processor – called the Minder BTE that can communicate to a nearby paired mobile phone. -A custom mobile phone application – called the Minder App installed on a mobile phone that permits the Minder BTE to communicate the captured EEG data from the Minder implant to the phone and ultimately to a secure cloud (known as the Minder cloud). The captured EEG from the Minder cloud can then be reviewed by trained clinical staff to detect seizures. The Minder App also captures the audio and accelerometer from the phone’s hardware and sends this to the Minder cloud. The Minder system is designed for collection of EEG data from people with epilepsy, day and night (24/7). This 24/7 collection of EEG data should allow clinicians to review EEG data during seizures. The purpose of this research is to evaluate the long-term safety of the Minder sub-scalp EEG monitoring system in patients with focal or generalised epilepsy. Subjects will be implanted with the investigational device for approximately 6 months, with long-term follow-up lasting up to 3 years post-implant. Each participant will have to undergo general anaesthestic surgery to have the Minder system implanted by a neurosurgeon. Participants will be trained to maintain the Minder system and have to keep a seizure diary (family/carers may help with this). Participants will also need to attend regular study visits. The participants can contact the study doctors by phone if they have any concerns. The study coordinator will communicate with participants by phone on a regular basis to arrange study visit appointments and check up on the participants.
Sponsors
Epi-Minder Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is aged between 18 and 75. 2. Subject speaks and reads English. 3. Established clinical diagnosis of focal or generalised epilepsy as defined by the ILAE (International League Against Epilepsy) criteria. 4. Subject and/or caregiver reports a minimum of two clinically identifiable epileptic events per month. 5. Subject can reasonably be expected to maintain a seizure diary and seizure monitoring device alone, or with the assistance of a competent individual. 6. Subject able to complete regular study visits and telephone appointments in accordance with the study protocol requirements. 7. A female subject must have a negative pregnancy test within two weeks prior to implant, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal. Undertake serum pregnancy test at enrolment. If the negative serum pregnancy test result exceeds the two-week limit, then a negative result from a urine pregnancy kit within two weeks of implant is needed.
Exclusion criteria
1. Subjects with significant progressive disorders or unstable medical conditions requiring acute intervention. 2. Active Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation device implanted for epilepsy or other conditions (e.g. cochlear implants). 3. Epilepsy surgery within 6 months prior to enrolment 6. A serious psychiatric disorder including unstable depression or where changes in pharmacotherapy are needed or anticipated during the study. 7. Subjects ineligible for device implantation surgery. 8. Subjects anticipated to have or with a high likelihood to have the following contraindicated treatments during the study: Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithotripsy and diathermy.
Outcome results
None listed