ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

U1111-1239-1830

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Epilepsy

Condition category

Condition code

Neurological

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]

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]

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]

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]

1. Comparison of subject-reported seizure events with seizure diary with Minder sub-scalp EEG.

Timepoint [1]

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]

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]

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]

3. Comparison of video and international 10-20 EEG gold standard seizure events with Minder sub-scalp EEG.

Timepoint [3]

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]

4. Evaluation of subject clinical acceptance and usability as a composite outcome.

Timepoint [4]

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]

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]

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?

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

22/11/2019

Actual

22/11/2019

Date of last participant enrolment

Anticipated

31/08/2023

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]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

The Alfred - Melbourne

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

Mater Private Hospital - South Brisbane

Recruitment hospital [6]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

3050 - Parkville

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

4101 - South Brisbane

Recruitment postcode(s) [6]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Epi-Minder Pty Ltd

Address [1]

384-388 Albert St, East Melbourne VIC 3002

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Department of Health and Human Services (Victoria)/Victorian Medical Research Acceleration Fund

Address [2]

Department of Health & Human Services
50 Lonsdale Street
Melbourne, 3000
Victoria, Australia

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

20/08/2019

Approval date [1]

13/11/2019

Ethics approval number [1]

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

Dr Amy Halliday

Address

41 Victoria Parade
St. Vincent's Hospital Melbourne
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9231 6970

Fax

[email protected]

Contact person for public queries

Name

Dr Alan Lai

Address

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

Australia

Phone

+61 3 9231 3296

Fax

[email protected]

Contact person for scientific queries

Name

Dr Alan Lai

Address

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

Australia

Phone

+61 3 9231 3296

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5741	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Seizure Forecasting Using a Novel Sub-Scalp Ultra-Long Term EEG Monitoring System.	2021	https://dx.doi.org/10.3389/fneur.2021.713794

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically