Australian Epilepsy Project

Not Applicable

Recruiting

• Conditions: Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12623000008628
• Lead Sponsor: Florey Institute of Neuroscience and Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-09
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Inclusion criteria
-Able to consent for themselves
-Over 18 and less than 65 years of age
-Able to understand the process of the study
-Fluent in English
-Referred by a Neurologist AND an EEG has been ordered or completed
-First-ever seizure cohort
-Diagnosis made no more than 3 months before referral
-Participants must have only ever had one unprovoked seizure, or cluster of seizures on a single day, that occurred no more than 6 months before referral
-Participants can be included with:
-Past history of febrile seizures
-Past history of provoked seizure(s) as per the ILAE (International League Against
Epilepsy) definition 86

New diagnosis of epilepsy cohort
-At least two unprovoked seizures (over any time frame, the most recent within 6 months of referral)
-Diagnosis of epilepsy made within 6 months of referral
OR
One seizure within 6 months of referral AND one or more of;
-Epileptiform discharges on EEG
-Epileptogenic lesion on CT
-Epileptogenic lesion on MRI
-Untreated or treated with anti-seizure medications (ASM) for less than 6 months at the time of referral

Drug-resistant epilepsy cohort
-Focal (or combined focal and generalised) epilepsy, with or without likely causative lesion on MRI
-At least one seizure in the 6 months prior to referral
-Two appropriate drugs in adequate doses have failed due to lack of efficacy (‘appropriate’ and ‘adequate’ as decided by the treating neurologist), including previous and current ASMs (e.g. on 1 current ASM and previously failed 1 or more ASM, or on 2 or more current ASMs)87
-Currently taking at least one ASM

Healthy Volunteers inclusion criteria:
Inclusion criteria
-Able to consent for themselves
-Over 18 and less than 65 years of age
-Able to understand the process of the study
-Fluent in English

Exclusion Criteria

Exclusion criteria
-Contraindications to research MRI scanning (including certain metal foreign bodies, pregnancy, severe claustrophobia, etc…)

-Developmental and Epileptic Encephalopathies (DEE)
-Moderate or severe intellectual disability
-Seizures solely due to provoking medical condition, medication, drug or alcohol use
-Age over 65 or under 18 at recruitment.
-Severe, intercurrent or progressive illness likely to EITHER
-Have a prognosis for survival under 24 months

OR

- In the opinion of the investigator will mask the importance to the individual participant of any improvement in their seizures (e.g. severe MS, dementia, etc)

OR

-Which leads to moderate disability requiring help with daily activities (equivalent to modified Rankin Score of 3 or more)

Note that disability solely due to frequency and severity of seizures is NOT an exclusion criterion.

First-ever seizure cohort
-More than one unprovoked seizure ever
-Febrile seizures with the last seizure before 6 years of age are permitted

Newly diagnosed epilepsy cohort
-Treated with ASM for epilepsy for more than 6 months at the time of referral.
-Treatment with ASM for other indications (e.g. neuropathic pain) is NOT an exclusion criteria

Those treated for more than 6 months are no longer Newly Diagnosed”, although they may qualify as Drug-Resistant in some cases

Drug-resistant epilepsy cohort
-Genetic generalised epilepsy syndromes
-Focal and generalised epilepsy syndromes where the focal seizures are associated with photosensitivity, such as idiopathic photosensitive occipital epilepsy, will not be included.

Other generalised epilepsy syndromes

Healthy Volunteer - Exclusion criteria
-Ever had provoked or unprovoked seizure(s)
-Febrile seizures with the last seizure before 6 years of age are permitted
-Contraindications to research MRI scanning (including certain metal foreign bodies, pregnancy, severe claustrophobia, etc…)
-Moderate or severe intellectual disability
-Age over 65 or under 18 at recruitment.
-Severe, intercurrent or progressive illness likely to EITHER

-Have a prognosis for survival under 24 months

OR

In the opinion of the investigator would have masked the importance to the individual participant of any improvement if included as an epilepsy participant (e.g. severe MS, dementia, etc)

OR

Which leads to moderate disability requiring help with daily activities (equivalent to modified Rankin Score of 3 or more)
-Have a condition that would preclude participation in project activities

Study & Design

• Study Type: Interventional
• Study Design: Not specified