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A prospective case-control study to develop biomarkers for individualised visual perturbation responses in epilepsy patients

A prospective case-control study to develop biomarkers for individualised visual perturbation responses in epilepsy patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000728639
Enrollment
24
Registered
2023-07-05
Start date
2024-03-04
Completion date
2025-04-22
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 p

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.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026