Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 19
- 主要终点
- Change in the Number of Moderate-to-severe Headache Days Per Month
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.
详细描述
Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
- •Evidence of intractability
- •Posterior-dominant head pain
- •Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
- •Onset of migraine before the age of 50
- •If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test
排除标准
- •Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
- •Untreated panic disorder
- •Untreated major depression evidenced by a PHQ-9 score >20
- •Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
- •Currently diagnosed with severe personality disorder
- •A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
- •Participating in another drug, device, or biologics trial within 3 months prior to Screening
- •A terminal illness associated with survival <24 months
结局指标
主要结局
Change in the Number of Moderate-to-severe Headache Days Per Month
时间窗: from Baseline to 6 months post-randomization
A moderate-to-severe headache day will be defined as any calendar day with: 1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR 2. a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.
次要结局
未报告次要终点