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Trial registered on ANZCTR


Registration number
ACTRN12619001587190
Ethics application status
Approved
Date submitted
26/08/2019
Date registered
19/11/2019
Date last updated
4/08/2023
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety assessment of a sub-scalp electroencephalography monitor
Scientific title
A prospective study to assess the safety of a sub-scalp monitoring device for the recording of brain electrical activity associated with the occurrence of epileptic seizures
Secondary ID [1] 299109 0
Nil known
Universal Trial Number (UTN)
U1111-1239-1830
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 314159 0
Condition category
Condition code
Neurological 312529 312529 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315377 0
Diagnosis / Prognosis
Comparator / control treatment
No control group for the primary objective of safety assessment of the device and its associated implantation and explantation procedures. All participants are receiving the intervention (i.e., Minder implant device) and there is no sham group of participants that would act as a comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321172 0
The primary outcome of this clinical trial is to evaluate safety of the test article. All adverse events both volunteered and solicited will be recorded.

Anticipated side effects include the following:
-Infection related to the device.
-Headaches related to the either insertion or removal surgery.
-Procedural pain and tenderness around the site of implant.
-Effects from the anaesthesia.

Additional side effects may include the following:
-Haematoma.
-Wound haemorrhage.
-Specific and general infections.
-Procedural and device related injuries.
-Soft tissue injury, including contusion (bruising).
-Implant site reactions.
-Cerebral-Spinal Fluid (CSF) collection.
-Suture rupture and/or wound breakage.
-Twiddler’s syndrome, when the subject “twiddle” or attempt to move the device under the skin, potentially causing device damage and/or injury.

The adverse effects with the highest chance of occurring are device related infection, procedural headache, medical device pain and anaesthetic complications.

Adverse events will be evaluated and differentiated by seriousness, causality of the event, and severity of the event. No statistical analysis is planned.
Timepoint [1] 321172 0
All adverse events through 6 months both volunteered and solicited will be recorded. Adverse events will be solicited at the time of device implantation, and at scheduled follow-up visits immediately post-op, and at 4-, 12-, and 24-weeks post implant. Any reported adverse event will be recorded, even outside of a scheduled study follow-up visit.
Secondary outcome [1] 374182 0
1. Comparison of subject-reported seizure events with seizure diary with Minder sub-scalp EEG.
Timepoint [1] 374182 0
1. Compare the seizures identified by Epileptologists reviewing the Minder sub-scalp EEG data against subject seizure diaries (current clinical practice for counting seizures.). This qualitative comparison will occur through 6-months post-implant after the device is switched on and recording.
Secondary outcome [2] 374183 0
2. Comparison of non-seizure prompted activity artifacts EEG signals with scalp electrodes positioned over the Minder electrodes with Minder sub-scalp EEG signals.
Timepoint [2] 374183 0
2. Compare the EEG artifact signals collected from the Minder implant against 4 scalp EEG electrodes positioned as close to the implanted sub-scalp electrodes as practically feasible. Comparison will be performed by Epileptologists review and spectral analysis of representative EEG data during activities including rest, closed eyes, jaw clenching, eye blinking, eye movements, and jumping on the spot at 4 weeks and 24 weeks post-implant.
Secondary outcome [3] 374184 0
3. Comparison of video and international 10-20 EEG gold standard seizure events with Minder sub-scalp EEG.
Timepoint [3] 374184 0
3. Compare the seizures identified by Epileptologists during the gold standard of video and international 10-20 scalp EEG monitoring against the Minder sub-scalp EEG at 4 weeks and 24 weeks post-implant.
Secondary outcome [4] 374186 0
4. Evaluation of subject clinical acceptance and usability as a composite outcome.
Timepoint [4] 374186 0
4. Subject acceptance and impression of usability of the device to obtain feedback on system design issues including coil on head, comfort, sleeping use, battery charging, and data back-up. This information will be collected using a study-specific patient questionnaire at 4- and 24-weeks post-implant.
Secondary outcome [5] 374187 0
5. Evaluation of patient reported outcomes (PROs). PROs include the following patient questionnaires as a composite outcome:
- Quality of Life in Epilepsy (QOLIE-89)
- Beck Depression Inventory (BDI)
- Beck Anxiety Inventory (BAI)
- Liverpool Seizure Severity Scale (LSSS)
Timepoint [5] 374187 0
5. Patient Reported Outcomes (PROs) will be evaluated at 4- and 24-weeks post-implant.

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

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Except for secondary endpoints 2 and 3, all primary and secondary endpoints will be based on qualitative analysis and reported as such. For secondary endpoint 2, EEG recordings will be analyzed visually and quantitatively. For secondary endpoint 3, the correlation between subject-reported and recorded seizure events with Spearman's rank correlation coefficient will be tested against the null hypothesis and Cohen's Kappa will be calculated to quantify the agreement between the three modalities in counting seizures.

A sample size of 25 subjects completing the 6-month follow-up will provide moderate statistical power. Data collected from all subjects will be analysed as a single group, when possible. All adverse events, even for subjects who drop-out and withdraw, will be reported for evaluating the safety of the investigational device.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14617 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 22945 0
The Alfred - Melbourne
Recruitment hospital [3] 22946 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 22947 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 22948 0
Mater Private Hospital - South Brisbane
Recruitment hospital [6] 25338 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 41042 0
2145 - Westmead
Recruitment postcode(s) [2] 38251 0
3004 - Melbourne
Recruitment postcode(s) [3] 38252 0
3050 - Parkville
Recruitment postcode(s) [4] 27641 0
3065 - Fitzroy
Recruitment postcode(s) [5] 38253 0
3084 - Heidelberg
Recruitment postcode(s) [6] 38254 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303644 0
Commercial sector/Industry
Name [1] 303644 0
Epi-Minder Pty Ltd
Country [1] 303644 0
Australia
Funding source category [2] 303648 0
Government body
Name [2] 303648 0
Department of Health and Human Services (Victoria)/Victorian Medical Research Acceleration Fund
Country [2] 303648 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Epi-Minder Pty Ltd
Address
384-388 Albert St, East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 303737 0
None
Name [1] 303737 0
Address [1] 303737 0
Country [1] 303737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304170 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 304170 0
Street address:
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Postal address:
Research Governance Unit
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [1] 304170 0
Australia
Date submitted for ethics approval [1] 304170 0
20/08/2019
Approval date [1] 304170 0
13/11/2019
Ethics approval number [1] 304170 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96034 0
Dr Amy Halliday
Address 96034 0
41 Victoria Parade
St. Vincent's Hospital Melbourne
Fitzroy VIC 3065
Country 96034 0
Australia
Phone 96034 0
+61 3 9231 6970
Fax 96034 0
Email 96034 0
amy.halliday@svha.org.au
Contact person for public queries
Name 96035 0
Dr Alan Lai
Address 96035 0
Department of Medicine at St. Vincent's Hospital Melbourne, The University of Melbourne Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy VIC 3065, Australia
Country 96035 0
Australia
Phone 96035 0
+61 3 9231 3296
Fax 96035 0
Email 96035 0
alan.lai@unimelb.edu.au
Contact person for scientific queries
Name 96036 0
Dr Alan Lai
Address 96036 0
Department of Medicine at St. Vincent's Hospital Melbourne, The University of Melbourne
Clinical Sciences Building,
Level 4 / 29 Regent Street,
Fitzroy VIC 3065, Australia
Country 96036 0
Australia
Phone 96036 0
+61 3 9231 3296
Fax 96036 0
Email 96036 0
alan.lai@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Epi-Minder Pty Ltd prefers to keep all data private except if required by authorities.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5741Ethical approval    378244-(Uploaded-18-11-2019-15-26-11)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5741Ethical approval    378244-(Uploaded-18-11-2019-15-26-11)-Study-related document.pdf

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSeizure Forecasting Using a Novel Sub-Scalp Ultra-Long Term EEG Monitoring System.2021https://dx.doi.org/10.3389/fneur.2021.713794