Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000231448p
Ethics application status
Submitted, not yet approved
Date submitted
30/05/2024
Date registered
31/03/2025
Date last updated
31/03/2025
Date data sharing statement initially provided
31/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of long-term continuous brainwave monitoring in people with epilepsy
Scientific title
Subscalp Electroencephalography (EEG) Augmentation For Accuracy and Reliability in Epilepsy Reviews (SEAFARER): a clinical trial in Adults With Epilepsy
Secondary ID [1] 310853 0
Alfred Health (sponsor) protocol number: SEA001
Universal Trial Number (UTN)
Trial acronym
SEAFARER
Linked study record
This study is a follow-up study to the study with registration record ACTRN12619001587190.

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 331887 0
Condition category
Condition code
Neurological 328617 328617 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 327268 0
Treatment: Devices
Comparator / control treatment
No formal control group. The comparator will be the 3-month baseline period during which the intervention data is not provided to clinicians or participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336420 0
Accuracy of Minder subscalp EEG system in recording seizures in comparison with traditional seizure diaries
Timepoint [1] 336420 0
The primary timepoints are as follows, relative to enrolment: - 3 months (end of baseline/beginning of intervention) - 6 months - 9 months (end of study/beginning of option al long-term follow-up)
Secondary outcome [1] 428300 0
Any change to accuracy of participant self-reporting of seizures over time
Timepoint [1] 428300 0
After enrolment, the relevant timepoints are as follows, relative to enrolment: - 3 months (end of baseline/beginning of intervention) - 6 months - 9 months (end of study/beginning of option al long-term follow-up)
Secondary outcome [2] 428301 0
Any change in clinical practice
Timepoint [2] 428301 0
Assessed at each clinical visit. The frequency and duration of which is at the discretion of the treating neurologist, but is expected to be monthly to 3-monthly after enrolment, and 15-30 minutes respectively.
Secondary outcome [3] 428302 0
A change in seizure frequency
Timepoint [3] 428302 0
Seizure frequency: continuously collected; reviewed at study visits (3, 6, and 9 months post-enrolment).
Secondary outcome [4] 428303 0
Patient experience and acceptability
Timepoint [4] 428303 0
At study exit (9 months post-enrolment)
Secondary outcome [5] 428304 0
A change in quality of life (main secondary outcome)
Timepoint [5] 428304 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [6] 428305 0
Cost-effectiveness of the intervention as measured by incremental cost-effectiveness ratio (ICER) Both direct healthcare costs and indirect costs in terms of productivity losses from participants and caregivers will be collected in questionnaires at baseline and each follow-up visit. Healthcare utilisation related to the device implantation will be excluded from this analysis, and a sensitivity analysis will be conducted by including these costs.
Timepoint [6] 428305 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [7] 437097 0
A change in seizure severity
Timepoint [7] 437097 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [8] 437104 0
Clinician acceptability
Timepoint [8] 437104 0
At study exit (9 months post-enrolment)
Secondary outcome [9] 437215 0
Health related quality of life (exploratory secondary outcome)
Timepoint [9] 437215 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [10] 437216 0
Change in depressive symptoms (main secondary outcome)
Timepoint [10] 437216 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [11] 437217 0
Change in depressive symptoms (exploratory secondary outcome)
Timepoint [11] 437217 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [12] 437218 0
Change in anxiety symptoms (main secondary outcome)
Timepoint [12] 437218 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [13] 437219 0
Change in anxiety symptoms (exploratory secondary outcome)
Timepoint [13] 437219 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [14] 437220 0
Change in adverse effects (main secondary outcome)
Timepoint [14] 437220 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.
Secondary outcome [15] 437221 0
Disability: SERIAS (Seizure Related Impairment Assessment Scale)
Timepoint [15] 437221 0
At study entry (enrolment), after baseline period (3 months), 6 months, and 9 months post-enrolment.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This will be a quasi-experimental (pre-post) study with two groups:
- the first group will consist of device-naive participants who will receive a subscalp EEG device implant as part of the intervention
- the second group will consist of participants from a previous safety/feasibility trial (ACTRN12619001587190) who already have a device implanted
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size & statistical methods

For the primary outcome, accuracy of seizure diaries, sensitivity/recall will be calculated using events marked as seizures in participant seizure diaries, versus events marked as seizures using the subscalp EEG data.

An estimated 15 new implants and 15 existing implants will be recruited, for a total of 30 participants that will contribute data for analysis. It is conservatively assumed that an average of 2 seizures will occur in each of the 30 participants over the 6-month intervention period. Considering subscalp EEG as the 'gold standard' with 100% accuracy in detecting seizures, and conservatively assuming a moderate intra-cluster correlation of 0.25, the sample size of 30 will have at least 80% power to detect if the sensitivity/recall of seizure diaries is less than or equal to 86% in a one-sample proportions test clustered by participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
14/10/2026
Actual
Date of last data collection
Anticipated
14/07/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 26616 0
The Alfred - Melbourne
Recruitment hospital [2] 26617 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 26618 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 26619 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [5] 26620 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 42656 0
3004 - Melbourne
Recruitment postcode(s) [2] 42657 0
3050 - Parkville
Recruitment postcode(s) [3] 42658 0
3084 - Heidelberg
Recruitment postcode(s) [4] 42659 0
3065 - Fitzroy
Recruitment postcode(s) [5] 42660 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315108 0
Government body
Name [1] 315108 0
NHMRC (National Helath and Medical Research Council) Medical Research Future Fund (MRFF)
Country [1] 315108 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Monash University, Victoria 3800 Australia
Country
Australia
Secondary sponsor category [1] 317126 0
Commercial sector/Industry
Name [1] 317126 0
Epi-Minder Pty Ltd
Address [1] 317126 0
384-388 Albert St, East Melbourne VIC 3002
Country [1] 317126 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314046 0
Alfred Hospital HREC
Ethics committee address [1] 314046 0
Ethics committee country [1] 314046 0
Australia
Date submitted for ethics approval [1] 314046 0
15/11/2023
Approval date [1] 314046 0
Ethics approval number [1] 314046 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130230 0
Dr Hugh Simpson
Address 130230 0
Alfred Centre, L6, 99 Commercial Rd, Melbourne VIC 3004
Country 130230 0
Australia
Phone 130230 0
+61 3 9903 94001
Fax 130230 0
Email 130230 0
[email protected]
Contact person for public queries
Name 130231 0
Hugh Simpson
Address 130231 0
Alfred Centre, L6, 99 Commercial Rd, Melbourne VIC 3004
Country 130231 0
Australia
Phone 130231 0
+61 3 9903 94001
Fax 130231 0
Email 130231 0
[email protected]
Contact person for scientific queries
Name 130232 0
Hugh Simpson
Address 130232 0
Alfred Centre, L6, 99 Commercial Rd, Melbourne VIC 3004
Country 130232 0
Australia
Phone 130232 0
+61 3 9903 94001
Fax 130232 0
Email 130232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.