Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000728639p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective case-control study to develop biomarkers for individualised visual perturbation responses in epilepsy patients
Scientific title
A prospective case-control study to develop biomarkers for individualised visual perturbation responses in epilepsy patients
Secondary ID [1] 309761 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 330165 0
Condition category
Condition code
Neurological 327041 327041 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves analysing brain electrical activity (EEG), during administration of intermittent photic stimulation. This will involve a single one hour session, with 5 stimulation blocks and a 5 minute rest in between each block. This is administered by experienced hospital staff at the Neurology Department of St Vincent's Hospital Melbourne.

During the session, you will be asked to sit on a comfortable chair, and your head will be measured with a measuring tape to determine the correct placement of the electrodes. The technician will then use a small amount of gel to attach the electrodes to your scalp. While the gel may feel slightly cool, it will not be uncomfortable. The gel helps to conduct the electrical signals from the brain to the electrodes. Electrodes will also be placed on the chest to record your heart rate. Once all the electrodes are in place, the technician will connect them to an EEG machine that will record the electrical activity. Setting up the electrodes initially should take no longer than 10-20 minutes. After the test, the electrodes will be removed from the scalp, and any remaining gel will be wiped away.

After setting up the electrodes, you will receive photic stimulation – viewing a flashing light – while your brain’s electrical activity is being recorded with an EEG machine. This procedure is usually called Intermittent Photic Stimulation (IPS), though we will instead be using a very similar, but extended protocol called Randomised and Repeated Intermittent Photic Stimulation (RRIPS). In routine IPS, photic stimulation involves a series of 10s flashing lights in an increasing frequency (the speed of flashing) order. If a photo-paroxysmal response (PPR: brain waves caused by photic stimulus that are associated with seizures) is observed on the EEG, stimulation frequencies are then presented in decreasing (slower) order. This is because the aim of routine IPS is to determine whether someone is photosensitive (light sensitive) or not, and the frequency range that causes a PPR.

In comparison, we will use the RRIPS protocol, where the photic stimulation frequency order is instead randomised. This is so we can remove any speed order effects which may occur, so that we know responses are not due to increasing or decreasing stimulation frequency. Also, instead of just one stimulation block, we will have 5 blocks. This is so we have multiple repeated examples for each stimulation frequency, to confirm that responses are consistent when repeated.

If PPR is observed on the EEG, the photic stimulation round will be ceased and a break will be initiated for at least 5 minutes, before continuing with the stimulation block.

The same procedure is administered for all participants.
Intervention code [1] 326206 0
Diagnosis / Prognosis
Comparator / control treatment
An age-matched control group will also undergo the same procedure.
Control group
Active

Outcomes
Primary outcome [1] 334906 0
The response to photic stimulation is measured using biomarkers of the EEG signal. These measures will include statistics of the timeseries, signal complexity, spectral information, and spatial synchrony. These will be evaluated together to indicate a composite outcome of cortical excitability.
Timepoint [1] 334906 0
Data will be assessed at the conclusion of the study.
Secondary outcome [1] 422383 0
None
Timepoint [1] 422383 0
NA

Eligibility
Key inclusion criteria
This study involves individuals a cohort of individuals with diagnosed epilepsy who are either additionally diagnosed with photosensitivity or not, and a separate healthy control (HC) group of participants who do not have any underlying neurological conditions. The following general inclusion criteria applies to all participants taking part in the study. The non-photosensitive epilepsy (NPE) inclusion criteria applies to the epilepsy cohort with a diagnosis of epilepsy but not photosensitivity, and the photosensitive epilepsy (PE) criteria applies to the sub-group of the epilepsy cohort that have a diagnosis of epilepsy as well as photosensitivity.

General Inclusion Criteria
a. Male and female participants 18 years and over.
b. English speaking, and basic levels of literacy in order to be able to give informed consent and to follow all instructions.
c. Normal or corrected vision.

Non-photosensitive Epilepsy (NPE) Inclusion Criteria
a. Formal diagnosis by SVHM Neuropsychiatrist of Epilepsy as defined by International League Against Epilepsy (ILAE) criteria (Scheffer, et al., 2017).

Photosensitive Epilepsy (PE) Inclusion Criteria
a. Formal diagnosis by SVHM Neuropsychiatrist of Photosensitive Epilepsy as defined by:
i. Observation of photo-paroxysmal response during intermittent photic stimulation in the EEG.
b. Formal diagnosis of Epilepsy as defined by SVHM Neuropsychiatrist of Epilepsy as defined by International League Against Epilepsy (ILAE) criteria (Scheffer, et al., 2017).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following healthy control (HC) exclusion criteria apply to the control group only. Epilepsy exclusion criteria apply to participants in the epilepsy cohort, including both NPE and PE subgroups.

Healthy Control (HC) Exclusion Criteria
a. History of photosensitivity, epilepsy, migraines or any other relevant disorder.

Epilepsy Exclusion Criteria
a. History of seizures triggered by intermittent photic stimulation, where a seizure is defined by the 2017 ILAE operational classification of seizure types (Fisher, et al., 2017), distinct from a photo-paroxysmal response, which is considered an electrographic event without severe clinical manifestations.

In addition to the exclusion criteria, subjects may be excluded by the study doctors based on their judgement. For example, if the subject is suspected of substance abuse or has any condition that may impact their ability to follow study procedure, their safety, or may jeopardise study participation.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24813 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 40461 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 313952 0
Hospital
Name [1] 313952 0
St Vincent's Hospital Melbourne
Country [1] 313952 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 315819 0
None
Name [1] 315819 0
Address [1] 315819 0
Country [1] 315819 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313089 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313089 0
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Ethics committee country [1] 313089 0
Australia
Date submitted for ethics approval [1] 313089 0
06/06/2023
Approval date [1] 313089 0
Ethics approval number [1] 313089 0

Summary
Brief summary
The primary objective of this study is to characterise the response to perturbation in epilepsy patients and healthy controls. This project will develop objective biomarkers to track changes in cortical excitability. These can be used to develop individualised response profiles that could be used in a clinical context to monitor a patient’s state including seizure risk, to evaluate anti-seizure medication (ASM) efficacy, and to predict outcomes like time to seizure freedom.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126962 0
Dr Dr Patrick O'Brien
Address 126962 0
Department of Neurology, St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Country 126962 0
Australia
Phone 126962 0
+61 3 9231 3045
Fax 126962 0
Email 126962 0
Patrick.obrien@svhm.org.au
Contact person for public queries
Name 126963 0
Ms Michaela Vranic-Peters
Address 126963 0
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Country 126963 0
Australia
Phone 126963 0
+61 3 9231 3045
Fax 126963 0
Email 126963 0
m.vranic-peters@student.unimelb.edu.au
Contact person for scientific queries
Name 126964 0
Ms Michaela Vranic-Peters
Address 126964 0
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Country 126964 0
Australia
Phone 126964 0
+61 3 9231 3045
Fax 126964 0
Email 126964 0
m.vranic-peters@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified EEG data with labels.
When will data be available (start and end dates)?
After publishing our initial study, aimed for before July 1st 2024, up until 7 years after data collection, July 1st 2031.
Available to whom?
Researchers and students.
Available for what types of analyses?
Any scientific research aligning with the aims in the study protocol, including IPD meta analyses.
How or where can data be obtained?
Upon request directly by contacting the research team (m.vranic-peters@student.unimelb.edu.au).


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.