DRKS00003689已完成未知
A randomized, controlled, double-blind, two-arm clinical trial to assess safety and efficacy of transcutaneous vagus nerve stimulation (t-VNS®) in patients with drug-resistant epilepsy - cMPsE02
cerbomed GmbH0 个研究点目标入组 77 人开始时间: 2012年4月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 77
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •To be eligible for inclusion into this study, the patient must fulfill all of the following criteria prior to enrollment:
- •Males or females = 18 and = 65 years of age.
- •Must be able to consent to participation by signing the informed consent form.
- •Has any of a broad range of epilepsy syndromes (e.g. with simple or complex partial or primary or secondary generalized seizures).
- •Has = 3 seizures per month and not more than 21 days between seizures, both prior to screening (assessed retrospectively) and during the baseline period.
- •Is on a stable regimen of = 3 antiepileptic drugs (AEDs), has been on this regimen for at least 5 weeks prior to study enrollment, and maintains this regimen throughout the participation in the study.
排除标准
- •To be eligible for inclusion into this study, the patient must not meet any of the following criteria prior to enrollment
- •Is participating in another clinical study at the time of this study, or has participated in another study within 30 days prior to signing the informed consent form.
- •Is pregnant or breast-feeding.
- •Is a sexually active female of child-bearing potential unless she is using a reliable, medically-approved primary-form of birth control. At the discretion of the investigator, total abstinence from sexual intercourse is acceptable in those cases where the age, career, lifestyle or sexual orientation of the patient ensures the prevention of a pregnancy.
- •Is an employee of the investigational site directly affiliated with this study and/or their immediate family members, an employee of the sponsor or the clinical research organization.
- •Is unwilling or unable to adhere to all study requirements, including accurate completion of the patient diary and questionnaires at the required time points and attending all study visits.
- •Is unable to understand the study plan, its conditions, the therapy goals and expected outcomes.
- •Has a substance use disorder (DSM-IV).
- •Has a major psychiatric disorder (Diagnostic and Statistics Manual of Mental Disorders), such as major depressive disorder or schizophrenia.
- •Has a deteriorating neurological or medical condition, including for example cerebrovascular degeneration or structural damage to basal ganglia.
- •Has any relevant cardiac disease, asthma, AIDS or HIV-infection or previous or current diagnosis of any form of cancer other than basal cell carcinoma.
- •Is using more than 3 AEDs at the time of study enrollment or at randomization.
- •Has a history of non-epileptic seizures.
- •Has had more than 1 episode of status epilepticus in the 6 months prior to study enrollment.
- •Has or has had invasive VNS or deep brain stimulation.
- •Has undergone ablative epilepsy surgery.
- •Has undergone cervical vagotomy.
- •Has a skin pathology or disease such as an infection, psoriasis, or eczema in the treatment area.
- •Has any anatomical pathology or other limitation that would prevent successful placement of the device.
- •Has an active implantable medical device such as a cardiac pacemaker, defibrillator, neurostimulator, cochlear implant, or active drug administration device.
- •Has any other serious medical condition that could adversely affect their participation in the study.
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