Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Structured Headache Diary Data for frequency of migraine
研究概览
简要总结
This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. By evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nVNS), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. If successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.
详细描述
Neuromodulation is a growing field in headache management. Technology ranges from invasive deep brain stimulation (DBS) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. Neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. The European Headache Federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. Vagus nerve stimulation (VNS), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura
排除标准
- •Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region
结局指标
主要结局
Structured Headache Diary Data for frequency of migraine
时间窗: Week 4
Diaries and calendars make possible to record prospectively the characteristics of every attack and this may reduce the recall bias and increase the accuracy of the description.
Multidimensional Pain Inventory (MPI) for migraine impact
时间窗: Week 4
The MPI was administered pretreatment. It is a 61-item self-administered questionnaire composed of 12 empirically derived scales designed to measure a patients' experiences of pain, their spouses responses to their pain, and their general activity levels
Numeric Pain Scale (NPS) for intensity of migraine
时间窗: Week 4
NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale
次要结局
- Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life(Week 4)