None listed
Conditions
Brief summary
People with epilepsy suffer not only from the effects of their chronic and disabling condition but also the uncertainty surrounding when and how it will affect them. New Australian technology that is currently under investigation - the Epiminder system - is designed to allow for continuous recording of brainwave activity (electroencephalography, or EEG) for months to years, using an implant under the scalp. This technology has the potential to offer unprecedented insights and certainty for patients and the clinicians who care for them. This project will evaluate this new 'subscalp' monitoring technology, to see how it can improve the lives of people with epilepsy. Specifically, we hypothesise (believe) that this new long-term subscalp brainwave monitoring will be more accurate than traditional methods of (people recording seizures in diaries), and that this increased accuracy will lead to better outcomes for people with epilepsy. NB: The Epiminder system is for investigational use only and it’s not approved in any geography.
Interventions
The Minder (TM) subscalp EEG device is an Australian-made and designed device for recording ultra-long-term electroencephalography (EEG) data. This EEG data is useful in monitoring for seizures and other disease activity in epilepsy. It has been created with cloud-based device management and data storage tools, together with the device described as the Epiminder system. The Epiminder system involves telemetry of subscalp EEG data to a companion app on a secure smartphone, which continuously stre
The Minder (TM) subscalp EEG device is an Australian-made and designed device for recording ultra-long-term electroencephalography (EEG) data. This EEG data is useful in monitoring for seizures and other disease activity in epilepsy. It has been created with cloud-based device management and data storage tools, together with the device described as the Epiminder system. The Epiminder system involves telemetry of subscalp EEG data to a companion app on a secure smartphone, which continuously streams the data to a secure cloud-based server maintained by the manufacturer (Epi-Minder Pty Ltd). This project will evaluate the utility of the Minder subscalp EEG device/system as an adjunct to routine face-to-face clinical care in people with epilepsy (‘augmented care’). There will be two groups of participants: (1) people with a Minder device in situ from a previous trial (ACTRN12619001587190), and (2) people without a device who will receive the new device as part of this trial. These participant groups will be pooled and enrolled in a pre-/post- intervention trial (quasi-experimental design). All participants will receive the augmented care intervention, which consists of providing the Minder subscalp EEG data to the treating clinician (which can also be shared with participants). After enrolment, there will be a baseline period of 3 months to allow for: - baseline data collection (all participants) - implantation of Minder devices (new implant group only) - Minder device checks (all participants) to ensure correct device function Implantation of the device is performed under general anaesthesia by a neurosurgeon. It involves the placement of the electrode array lead and telemetry unit under the scalp, and takes approximately one hour. At the first postoperative visit (new implants) or screening visit (existing implants) participants will be instructed on the use of the device, including charging, care, and maintenance. At the same visit, Minder device checks will be carried out, including: impedance checks, signal quality, and general device function. After the baseline period, monthly reports will then be generated based on the Minder device data for 6 months. The intervention period will consist of (1) access to the monthly reports, (2) access to the cloud-based Minder EEG data. The treating neurologist will be administering the intervention. The monthly reports from the Minder device will be sent to the treating neurologist, who can choose to act on and share the information with participants as they see fit. These reports will include a summary of epileptic EEG activity recorded by the Minder device, as well as adherence data, reflecting the percentage daily use of the system. Study visits will be conducted 3-monthly. The frequency of clinical visits is determined by the treating neurologist. They may choose to arrange visits monthly with study reports, 3-monthly with study visits, or otherwise. The duration of appointments is at the discretion of the treating neurologist and their specific institutional policy, but is anticipated to reflect standard clinical appointment times (e.g. 15-30 minutes for reviews). The primary outcome will be accuracy of participant recorded seizure diaries, compared with the Minder EEG recordings. Secondary outcomes include: changes to clinical practice (see below); and changes to: mood, quality of life, disability, seizure frequency, seizure severity, and side effects. A health economic impact analysis will also be conducted, as well as an implementation evaluation (see below). Changes to practice as part of augmented care will be recorded, and include: - Change to assessment of seizure frequency or seizure-freedom status - Change to epilepsy diagnosis or classification - Change to anti-seizure medication prescription - Change to neuromodulation treatment - Change in visit timing and frequency - Change in driving eligibility - Change in eligibility for advanced treatments The trial will conclude after the 6-month intervention period (9 months). An implementation evaluation will be conducted at study exit, to assess acceptability of the augmented care intervention, and changes to the way people see themselves when using the Minder device. This will consist of semi-structured interviews and surveys of participants, and surveys of neurologists and neurosurgeons experience with the Minder system. After the conclusion of the study, there will be an optional extension phase of up to 3 years during which Minder device data and safety data will continue to be acquired and recorded. During this period the treating clinicians for all participants may continue to access the Minder data. This study is a follow-up study to a previous safety and feasibility study (ACTRN12619001587190).
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
New implant group: - Adults age 18-75 years old - Established clinical diagnosis of focal, generalized, or mixed focal & generalized epilepsy; as defined by (ILAE International League Against Epilepsy) criteria - Previous scalp EEG recordings demonstrating typical ictal (seizure) activity within 5 years - Seizure frequency is uncertain, and this uncertainty is clinically significant - An estimated seizure frequency of at least one every 3 months. This may be a seizure frequency estimated/suspected by managing clinician, an event frequency reported by the patient/carer, or event frequency suggested by objective diagnostic testing. - Prior neuroimaging within the last 5 years where applicable - Except for epilepsy, must be medically and neurologically stable, as judged by clinician - Participant anatomy must permit implantation of a subscalp EEG device - Participant/caregiver must be able to speak and read English - Participant/caregiver can be reasonably expected to maintain a seizure diary alone or with the assistant of a competent individual - Participant, with the assistance of caregiver where necessary, is able to complete regular study visits and telephone or telehealth appointments in accordance with the study protocol Additional requirements for participants who were assigned female sex at birth: - Have a negative pregnancy test within 2 weeks prior to implant - If sexually active, must be using a reliable form of contraception, surgically sterile, or be at least 2 years post-menopause Existing implants group: - Any participants from the previous Minder safety study who: o Have completed 6 months of follow-up o Still have a Minder device (ie, did not have it removed) o Have demonstrated adequate device compliance (as judged by the site lead) including an average of at least 20% device usage during the original safety study. o Have seizures reliably detected/recorded on the Minder subscalp EEG device o Have a seizure frequency that is uncertain, and this uncertainty is clinically significant o Have an estimated seizure frequency of at least one every 3 months. This may be a seizure frequency estimated/suspected by managing clinician, an event frequency reported by the patient/carer, or event frequency suggested by objective diagnostic testing. This study is a follow-up study to an original safety and feasibility trial (ACTRN12619001587190)
Exclusion criteria
New implant group: - Participants with progressive neurological disorders, unstable medical conditions, or terminal medical conditions - Other implantable neurostimulation devices that preclude safe placement and normal operation of subscalp EEG device (e.g. deep brain stimulation – DBS – systems, Cochlear implants, etc), as judged by a neurosurgeon (NB: VNS, vagus nerve stimulation, is not an exclusion criteria) - Epilepsy surgery within 6 months prior to planned implant date - Severe or unstable psychiatric condition, that in the judgement of the participant’s treating neurologist/epileptologist, psychiatrist, or an investigator would preclude the ability to participate in the trial or where participation would represent a risk for the participant - Moderate to severe cognitive or intellectual impairment, that in the judgement of the participant’s treating neurologist/epileptologist, psychologist, psychiatrist, or an investigator would preclude the ability to participate in the trial - Active suicidal plan/intent in the past 6 months, history of suicide attempt within 2 years, or more than one lifetime suicide attempt - Implantable cardiac pacemakers/defibrillator - Ineligible or unsafe for surgery, as judged by neurosurgeon, due to any of the following: o Bleeding diathesis due to oral antiplatelets, oral anticoagulants, platelet dysfunction, or other coagulopathy; unless otherwise agreed by a hematologist, neurosurgeon, and investigator o Ineligible for cranial surgery o Ineligible for or unable to tolerate a general anesthetic o Unacceptably increased infection risk, for example due to inherited, acquired, or treatment related immunosuppression; unless otherwise agreed by an investigator and neurosurgeon. o Major abnormality on clinical or laboratory testing that may preclude study participation - Subjects unable to consent for themselves - Recent scalp infection of skin breakdown within 6 weeks prior to implant - Subjects likely to require, or have high likelihood of having, the following during the study period: magnetic resonance imaging (MRI), electroconvulsive therapy (ECT), lithotripsy or diathermy. - Elective international travel planned during the 9-month study period (emergency travel is acceptable). - Participants may be excluded by the study doctors based on their judgement, and this may include anticipation that participants may be unable to follow study protocols or participate for any reason, or concern about elevated safety risk for participants Existing implants group: - Inadequate compliance, as judged by the site lead or investigator - Typical epileptic seizures not recordable / not captured on subscalp EEG device
Outcome results
None listed