NCT01178437已完成不适用
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy - a Prospective Pilot Study Regarding Safety, Effectiveness and Clinical Performance
cerbomed GmbH2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Assessment of performance
研究概览
简要总结
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Patients of both gender, aged from 18-75 years
- •Diagnosis of epilepsy according to the diagnosis criteria of the DSM IV/ ICD 10 (especially G 40.1 /G 40.2/ G 40.3)
- •Insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high
- •Antiepileptic Drugs (AED) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase
排除标准
- •Absence of Informed Consent
- •Pregnancy
- •Psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, Borderline personality disorders (BPD), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity.
- •Abuse of drugs and alcohol until 12 weeks before study start
- •Cerebrovascular diseases
- •Severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, "Gamma Knife Surgery")
- •Indications of structural impairment of the basal ganglia or the brain stem
- •active implants (e.g. cochlea implants, VNS, pacemaker)
- •Severe neurological diseases (e.g. Morbus Parkinson, systemic neurologic diseases
- •severe internistic diseases (e.g. arterial hypertension, respiratory failure)
- •Bronchial asthma
- •malignant diseases of any kind, within five years before study start
- •Severe active infectious diseases (e.g. HIV, hepatitis)
- •Bone diseases (e.g. Morbus Paget, recent fractures)
- •Diseases of the ENT body system: Hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna
- •Concurrent participation in other studies
- •Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
结局指标
主要结局
Assessment of performance
时间窗: 9 months
rated by investigator QOLIE-89 MADRS CCTE
次要结局
- Patient's subjective assessment of epileptic shocks(9 months)
- Further assessment of performance(9 months)
- Assessment of Safety(9 months)
研究者
研究点 (2)
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