NCT06862674已完成不适用
Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine
Neurent Medical7 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Mean Change from Baseline in Monthly Migraine Headache Days
研究概览
简要总结
Clinical exploration of NEUROMARK System in Participants with Chronic Migraine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Must:
- •Be ≥18 years of age.
- •Have Chronic Migraine
- •Be willing and able to comply with all study elements, as indicated by written informed consent.
排除标准
- •Participant Must Not:
- •Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction.
- •Progressive neurologic disorder other than migraine.
- •Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- •Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
- •Have had previous sinus or nasal surgery within 6 months of study enrollment.
- •Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis.
- •Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized.
- •Have an acute nasal or sinus infection.
- •Have nasal mucosal erosion/ulceration.
- •Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure.
- •Have hemophilia.
- •Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- •Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
- •Have had previous head and/or neck irradiation.
- •Be pregnant.
- •Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the participant at risk, could confound the study results, or may interfere significantly with the participant's participation in the study.
- •Be participating in another clinical research study.
研究组 & 干预措施
Single-arm Treatment
Experimental
Participants that provide informed consent and meet study eligibility requirements will receive treatment. Participants will have the NEUROMARK System applied to both nostrils during a single session.
干预措施: NEUROMARK System (Device)
结局指标
主要结局
Mean Change from Baseline in Monthly Migraine Headache Days
时间窗: 6 months
Monthly headache logs were used to record headache frequency, intensity, duration, and pain. Mean change from baseline in number of migraine headache days per month was assessed over 6 months.
次要结局
未报告次要终点
研究者
研究点 (7)
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