ACTRN12623000008628招募中未知
Australian Epilepsy Project - A project developing improved epilepsy diagnostics and prognostics through advanced imaging, neuropsychology and genetics for people with epilepsy
Florey Institute of Neuroscience and Mental Health0 个研究点目标入组 4,000 人开始时间: 2023年1月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •- 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)
- •-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
- •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)
- •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
研究者
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