A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Frequency in headache days
研究概览
简要总结
The purpose of this study is to assess short- and long-term safety, tolerability and efficacy of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from chronic migraine refractory to conventional medical therapy.
详细描述
- Introduction 1.1 Background Migraine is a common disabling headache disorder. Patients with Chronic Migraine (CM) experience headache on a minimum of 15 days per month. CM is associated with significant disability and reduced quality of life .
Since the late 1990s, there has been considerable progress in neurostimulation techniques to treat medically intractable chronic-headache syndromes patients, by applying peripheral-nerve stimulation to patients . It is indeed well demonstrated that a non-painful stimulation of peripheral nerves can elicit analgesic effects, and that occipital nerve stimulation (ONS), by retrograde activation of the trigemino-cervical complex can provide effective pain relief in patients with headache disorders, including migraine. Recently, high cervical spinal cord stimulation (SCS) has been tested for the treatment of chronic cluster headache , highlighting a potential benefit of SCS over ONS: SCS exerts an immediate and almost maximal effect, which allows a test phase prior to implantation of the pulse generator with the possibility of removing the electrode in case of insufficient pain relief.
Both SCS and ONS produce paresthesia, an unpleasant tingling sensation for the patients In recent prospective studies, a new modality of SCS, High Frequency (HF) SCS, has been demonstrated to be effective and safe in a chronic pain population, the Failed Back Surgery Syndrome (FBSS) population . High Frequency SCS differs from conventional SCS in several ways, which present significant advantages to both the patients and the healthcare professionals: 1) absence of paresthesia (tingling) which leads to greater patient comfort and acceptance of the therapy, 2) shorter procedural time as no paresthesia mapping is needed, and 3) increased efficacy compared to conventional SCS, demonstrated in the FBSS population. Additionally, HF SCS has a similar safety profile as conventional SCS.
HF-SCS may thus combine the advantage of paresthesia free therapy (and thus greater patient tolerability of the therapy) with the possibility of testing the therapy during a trial phase prior to the implantation of a permanent pulse generator. 2. Study Objective, Outcomes, and Design 2.1 Objective The objective of this study is to investigate the safety, efficacy and tolerability of high frequency (HF) Spinal cord stimulation (SCS) for the treatment of patients with chronic migraine.
2.2 Outcomes
- Change of frequency in headache days from baseline;
- Change of frequency in migraine days from baseline;
- Change in frequency of moderate/severe headache days from baseline;
- Change in headache pain Visual Analog Scale (VAS) score from baseline;
- Change in HIT-6 score from baseline;
- Change in Migraine Disability Assessment (MIDAS) Score from baseline;
- Change in frequency of triptans intake from baseline;
- Patient Global Impression of Change (PGIC);
- Change in Quality of Life from baseline;
- Change in the number of sleep disturbances per night from baseline;
- Incidence of device-related adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An adult between the age of 18 and 65
- •Capable of providing informed consent
- •A diagnosis of chronic (>15 or more headache-days per 4 week period for more than 3 months, with an headache-day being defined as a day with an attack lasting a minimum of 4 hours) migraine refractory to conventional medical treatment (has failed at least 2 preventive and 2 abortive drugs) as per the ICHD-II guidelines.
- •On optimal and stable preventive headache pharmacological migraine therapy for at least 2 months
- •Failed treatment with Onabotulinumtoxin A for 12 months
- •Able to comply with the requirements of the study visits and self-assessment questionnaires Able to provide informed consent and willing to comply with study procedures
排除标准
- •• medication-overuse headache
- •Had treatment with Onabotulinumtoxin A in the last 3 months
- •An already implanted active medical device
- •A contraindication to the cervical placement of SCS lead
- •A life expectancy of less than 1 year
- •A female of child bearing potential who is pregnant/lactating or not using adequate birth control
- •Beck Depression Inventory score of >24
- •Evidence of an active disruptive psychological/psychiatric disorder or other known condition significant enough to impact perception of pain (e.g. fibromyalgia), compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
- •Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day), and/or medication
- •Bleeding diathesis such as coagulopathy or thrombocytopenia
- •Immuno-compromised and at risk for infection
- •Diabetic which is not under control as determined by the Investigator
- •Unresolved issue of secondary gain
- •Inability to manage the technical demands of the SCS equipment
- •Currently participating in a randomized clinical trial with an active treatment arm or planned to be enrolled in another clinical trial
结局指标
主要结局
Frequency in headache days
时间窗: three and six months
Change of frequency in headache days from baseline
Frequency in migraine days
时间窗: three and six months
Change of frequency in migraine days from baseline
Frequency of moderate/severe headache days
时间窗: three and six months
Change in frequency of moderate/severe headache days from baseline
次要结局
- headache pain Visual Analog Scale (VAS)(three and six months)
- HIT-6(three and six months)
- Migraine Disability Assessment (MIDAS)(three and six months)
- Frequency of triptans intake(three and six months)
- Patient Global Impression of Change (PGIC)(three and six months)
- Quality of Life(three and six months)
- sleep disturbances(three and six months)
- Device-related adverse events(Three and six months)
研究者
Paolo Martelletti
Professor, Internal Medicine
University of Roma La Sapienza