A Prospective Observational Clinical Study to Investigate the Relationship Between Seizure Frequency and BioEP During ASM Titration in Newly Diagnosed Patients With Epilepsy, and to Assess the Utility of BioEP as an Early Prognostic Indicator of Anti-seizure Medication (ASM) Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 主要终点
- The relationship between BioEP and seizure frequency.
研究概览
简要总结
This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy
详细描述
The study will consist of a cohort of adult patients who present to first seizure clinics. The patients will have had an EEG performed as part of the clinical care pathway (this will act as their baseline reference BioEP value). They will also have received an epilepsy diagnosis and will be due to start ASM titration as part of their epilepsy treatment. One stop clinics shall be targeted primarily for their same day EEGs service, to allow a baseline EEG to be obtained prior to the patient starting ASMs in those who get an EEG diagnosis on the same day.
Patients who have initially seen a Neurologist in a first seizure clinic and are under a period of watchful waiting, and then return to the clinic a second time and receive an epilepsy diagnosis will be eligible to enter the trial. The second encounter with Neurology would usually be due to the occurrence of a second seizure or by a positive EEG being recorded as part of their usual care during the watch and wait period and the clinician deciding to start ASMS on that basis. The study will utilise their 1st EEG performed as the baseline EEG (provided this is performed within a 12-month window prior to their second Neurology encounter and during a period of no ASMs).
A baseline BioEP result shall be gathered from baseline EEG data prior to commencement of the ASM titration regime and a set of computational biomarkers (BioEP) shall be identified from relevant EEG segments free of IEDs. In addition to the clinical care pathway, participants will also receive additional routine EEGs at 1, 3 and 6 and 12 months after commencing treatment. The EEGs performed at 1, 3, 6 and 12 months duration shall also have their BioEP results identified at these specified time points.
Any patient who requires a ASM medication change during the first 6 months of the trial, an additional EEG will be collected at 9 months, and then again at the usual 12 months' time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18 and above) presenting with first suspected seizure(s).
- •Able to give informed consent.
- •Patient has received an initial epilepsy diagnosis.
- •Patient accepts decision to commence ASM.
- •Have an EEG prior to commencing ASMs.
- •Participants under watchful waiting who subsequently return to clinic for an epilepsy diagnosis (following a second seizure or a positive EEG) can be included in the study. They must have had an EEG performed in the 12 months prior to be being included in the study (to be used as a baseline EEG) and not have been taking any ASMs at the time.
排除标准
- •Participants unable to tolerate an EEG test so no EEG data were gathered.
- •Participants with a known hepatic/renal encephalopathy.
- •Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
- •Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
- •Patient receiving low does ASMs for other conditions (migraines etc).
结局指标
主要结局
The relationship between BioEP and seizure frequency.
时间窗: 12 months
Identify a ratio of change of BioEP result from baseline (prior to ASMs commencing) to maximal effects of the ASM intervention and seizure control.
次要结局
- Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change(12 months)