Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE (OPTIMISE)
2020年11月10日 更新者：Boston Scientific Corporation
Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
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.
研究概览
详细说明
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).
研究类型
介入性
注册 (实际的)
28
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Valencia、California、美国、91355
- Boston Scientific Clinical Research Information Toll Free Number
-
-
Illinois
-
Chicago、Illinois、美国、60612
- University of Illinois at Chicago (Implanting Physician)
-
Chicago、Illinois、美国、60642
- Diamond Headache Clinic (Headache Physician)
-
-
Louisiana
-
Shreveport、Louisiana、美国、71105
- Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
-
-
Michigan
-
Detroit、Michigan、美国、48202
- Henry Ford Hospital (Headache Physician)
-
West Bloomfield、Michigan、美国、48322
- Henry Ford Medical Group (Implanting Physician)
-
-
Missouri
-
Springfield、Missouri、美国、65804
- Mercy Pain Management -Surgery Center (Implanting Physician)
-
Springfield、Missouri、美国、65807
- Clinvest Research, LLC (Headache Physician)
-
-
New York
-
Bronx、New York、美国、10461
- Montefiore Headache Center (Headache Physician)
-
New York、New York、美国、10016
- NYU Medical Center (Implanting Physician)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment
The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
|
Electrical stimulation of the greater occipital nerve
其他名称：
|
|
有源比较器：Control
The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
|
Electrical stimulation of the greater occipital nerve
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Number of Moderate-to-severe Headache Days Per Month
大体时间：from Baseline to 6 months post-randomization
|
A moderate-to-severe headache day will be defined as any calendar day with:
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. |
from Baseline to 6 months post-randomization
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Richard Lipton, MD、Albert Einstein College of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年4月10日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2017年1月19日
研究注册日期
首次提交
2013年1月23日
首先提交符合 QC 标准的
2013年1月23日
首次发布 (估计)
2013年1月25日
研究记录更新
最后更新发布 (实际的)
2020年11月13日
上次提交的符合 QC 标准的更新
2020年11月10日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Occipital nerve stimulator的临床试验
-
Chonbuk National University HospitalSamsung Medical Center; Pusan National University Yangsan Hospital未知
-
Seoul National University Hospital未知
-
Tel-Aviv Sourasky Medical CenterBeth Israel Deaconess Medical Center; Tel Aviv University未知