Clinical Study for the Validation of the Medical Device Mjn-SERAS for the Detection and Prediction of Epileptic Seizures in Individuals from 12 to 65 Years, Suffering from Drug-resistant Epilepsy During Their Day-to-day Activity, to Find Out the Impact of the Digital Solution in the Quality of Life in a Normalised Environment and Provide Valuable Information from Real-World Data.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Change in quality of life index of patients with epilepsy
研究概览
简要总结
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology of their epilepsy is considered to be of interest for the validation in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe with CE mark Class IIa.
This new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy to determine the impact in quality of life of the mjn-SERAS on the early detection of epileptic seizures and the generation of a pre-seizure alert with a time window of a minimum of 1 minute.
详细描述
A prospective, multicentre, postmarketing, with a controlled and randomized design, clinical study is proposed to validate in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe by BSI(British Standard Institution) Group (CE2797) notified body CE 685187. The study will be performed in Spain, Germany and UK (United Kingdom).
The patient's characteristics about epilepsy, drug-resistant epilepsy, inclusion and exclusion criteria for the study, considering the same classification in ICD-10 (International Statistical Classification of Diseases) for Spain and NHS(National Health Services) in the UK, and ICD(International Classification of Diseases) ICD-10-GM for Germany, and the target population where the researchers will study the solution are the same for the 3 countries, so all are considering the international standards from ILAE(International League Against Epilepsy) 2017 classification, including German Society for Epileptology and ILAE British Chapter, defined in next sections.
This new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy, according to CE mark considerations and intended use, which will make it possible to determine the impact of the mjn-SERAS on the early detection of epileptic seizures and the generation of a pre-seizure alert with a time window of a minimum of 1 minute. The sensitivity, specificity and accuracy of the medical device solution in the studied environment will also be calculated.
The pre-determined sample size determined is an n=130 exposed individuals who meet the inclusion criteria. The patients will be recruited in Spain, Germany, and UK. The pre-post assessment for each patient will allow to compare data before and after the use of the mjn-SERAS solution, creating a baseline initially and a final evaluation. A control group will be randomized to assess the difference between both groups.
The method applied during the study consists of using a mjn-SERAS, software application with the earpiece of the external auditory canal customised for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age criterion:
- •o Patient must be 12 to 65 years of age inclusive, at the time of signing the informed consent.
- •Clinical criteria:
- •Confirmed diagnosis of drug-resistant*1 epilepsy, with focal, generalized or focal -generalized seizures, according to international standards from ILAE 2017 classification*2 (link), who will be evaluated by a specialised epilepsy unit and who are expected to have seizures.
- •The video-EEG records of patients must have epileptic seizures counted and recorded by specialised clinical personnel through accepted and contrasted gold-standard systems*3 or evaluated by a specialized epilepsy unit and expected to experience seizures with electroclinical manifestations If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
- •Patients with a clinical history and previous video-EEG records that allows certainty about the diagnosis and characteristics of the participant's epilepsy. If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
- •Precise semiological information on the patients included.
- •Patients with both sides localisation will be accepted, and the wearable device will be placed in the side that is most evident the origin of the seizures, to be placed as near as possible to the focal point.
- •Presence of more than 10 day seizures per year, from tonic, tonic-clonic, clonic or atonic seizures, and a minimum of 2 to 4 day seizures per month (preferably 4 per month/ 1 per week) during the last 3 months, reported by the patients/caregivers or assessed by the neurologist through the patient history. The patient must have seizures during the day to record them, not just seizures at night.
- •Patients included in ICD-10*4 and ICD-10-GM*5 classification as G40 with electroclinical manifestation of seizures.
- •G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple focal seizures
- •G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex focal seizures
- •G40.3 Generalized idiopathic epilepsy and epileptic syndromes
- •G40.6 Grand mal seizures, unspecified (with or without petit mal). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).
- •G40.8 Other epilepsies (Epilepsies and epileptic syndromes, undetermined whether focal or generalized). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).
- •o In case of epileptic syndromes not listed in the above or shows some of the syndromes mentioned in the exclusion criteria, patients could be included according to medical criteria defined by the clinician. These criteria must be accordingly justified by the clinician ( e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording).
- •Technological criteria:
- •Ability to navigate in Android or iOS operating system. If mild or moderate disability, family members can assist with navigation if patient is unable. The smartphone must stays with the patient to record EEG, but seizures are registered by a family member.
- •Exclusion criteria
- •Presence of psychogenic seizures.
- •If there is a coexistence of epileptic and non-epileptic seizures, it will be considered an exclusion criterion if the patient or family cannot differentiate between the two types of seizures.
- •If the patient or family can always differentiate between the two types of seizures, the patient could be included in the study according to medical criteria (but only recording the epileptic seizures.)
- •Psychiatric, neurological, or systemic disorders that the researcher believes could affect the realisation and interpretation of the results.
- •Presence of more than 10 seizures per day on a habitual basis.
- •Presence of epilepsia partialis continua (G40.5*4*5)
- •Patients with legal representative
- •Pregnant women
- •Patients with only absence seizures (G40.A*4,G40.4*5)
- •Patients with only myoclonic seizures or epileptic spasms (G40.B*4,G40.4*5).
- •Patients included in ICD-10*4 and ICD-10-GM*5 classification and not included in the medical criteria for specific epileptic syndromes in inclusion criteria.
- •G40.0 Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
- •G40.4 Other generalized epilepsy and epileptic syndromes. In case of specific epileptic syndromes, patients could be included according to medical criteria (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording)
- •G40.5 Epileptic seizures due to external causes*4 or Special epileptic syndromes*5
- •G40.7 Petit mal, unspecified, without grand mal seizures
- •G40.9 Epilepsy, unspecified
- •Participants in previous clinical trials with mjn-SERAS device.
- •In the case the patient presents an epileptic syndrome mentioned in the exclusion criteria, the patient if the clinician considers the subject meets medical criteria to be included, the patient can be enrolled in the study. These criteria must be accordingly justified by the clinician (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording
排除标准
- 未提供
结局指标
主要结局
Change in quality of life index of patients with epilepsy
时间窗: 6 months
1. To assess the quality of life of patients with epilepsy and the degree of health perceived by the patient when using the mjn-SERAS solution to generate alarms when the possibility of a new epileptic seizure is anticipated. • Endpoint : Change from baseline in the epilepsy-related quality of life (QOLIE-31 questionnaire for adults 18 to 65 and QOLIE-AD-48 questionnaire for adolescents 12 to 17) after the use of the mjn-SERAS solution during T2 period, assessed in T3 period and including pre-post assessment and comparison between intervention and control group. • Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) QOLIE-31, Quality of Life Index Epilepsy and QOLIE-AD-48
Patient's safety associated with seizure-related accidents
时间窗: 6 months
2. To assess the evolution of the patient's safety related with seizure-related accidents in patients with epilepsy when using the mjn-SERAS solution. * Endpoint Change from baseline in the number of seizure-related accidents and injuries during the use of the mjn-SERAS solution in the T2 period, assessed in T3 period, including pre-post assessment and comparison between intervention and control group. * Evaluation Evaluation will be performed at the T3 period with a comparison of number and severity of accidents between control group, as baseline, and intervention group, using the device.
次要结局
- Change in health resources utilization(12 months)
- Seizure correlation for patients report(12 months)
- Change in quality of life 5D of patients with epilepsy(6 months)
- Change in social relationships and role limitations(12 months)
- Change in mental and emotional well-being(12 months)
- Seizure correlation for patient knowledge(12 months)
- Medical device performance(12 months)
- Device safety evaluation with questionnaire(12 months)
- Device safety evaluation and adverse effects(12 months)