Relief of Migraine Pain Through Transcutaneous Electro Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Migraine relief at 2 hours post treatment as determined by difference of reported pain levels at the beginning and 2 hours after the end of electro stimulation session. Pain levels are assessed by means of Numerical Pain Scale.
研究概览
简要总结
This study will evaluate transcutaneous electro stimulation device developed by Siano for adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for migraine sufferers.
详细描述
This study will gather information regarding performance of Avital transcutaneous electro stimulation device developed by Siano. Electrostimulation in the form of weak electrical pulses arranged in specific patterns (programs), is delivered through adhesive electrodes attached to patient's skin. A set of stimulation programs, out of which one is placebo, is stored in device memory.The device is controlled wirelessly using a dedicated smartphone application. Participants will be instructed to attach and activate the device at the onset of a migraine attack and manually adjust stimulation intensity to a level where it is perceivable but not painful. Upon each activation, a program will be automatically picked for execution in random order. Randomization is performed within and between subjects. Subjects will not be aware of the executed program. Subjects are requested to refrain from use of migraine relief drugs prior to treatment and during the first two hours of the treated attack. Throughout the course of electrostimulation, participants will be requested to rate their migraine pain level via te same smartphone application, using Visual Analog Scale (VAS).
Overall experimental duration for each participant will be determined by the goal of using the Avital device for 10-20 migraine attacks.
Data containing activation times, executed programs, stimulation intensity and user feedback will be transmitted via the smartphone to a central database for analysis. All data are completely de-identified and linked to a unique code assigned to each device. The link between participant's ID and this code will be securely maintained by the research coordinator. Database will be overseen by Siano staff responsible for monitoring the clinical study. The electronic database will be used to generate outcome measures.
In the course of this study the investigators will obtain controlled data on the safety and efficacy of transcutaneous electro stimulation for migraine treatment using Siano developed transcutaneous electro stimulation device.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Matches International Headache Society criteria for migraine with and without aura
- •Reports 2-8 migraine attacks per month
排除标准
- •Has other significant pain problem (e.g.cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the investigator may confound the study assessments
- •Has severe cardiac or cerebrovascular disease
- •Has uncontrolled high blood pressure (systolic >160 diastolic > 100 after 3 repeated measurements within 24 hours)
- •Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator)
- •Known epilepsy
- •Use of Cannabis including medical use.
- •Has chronic migraine (more than 15 headache days per month).
- •Has undergone nerve block (occipital or other) in the head or neck within the last 2 months.
- •Has received Botox injections within the last 6 months.
- •Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use an accepted form of birth control.
结局指标
主要结局
Migraine relief at 2 hours post treatment as determined by difference of reported pain levels at the beginning and 2 hours after the end of electro stimulation session. Pain levels are assessed by means of Numerical Pain Scale.
时间窗: 2.5 hours
Percent responders resulted in significant pain relief at 2 hours post treatment
时间窗: 2.5 hours
Percent of responders with improvement of 50% or better in pain level according to NPS
Relative migraine pain relief at 2 hours post treatment
时间窗: 2.5 hours
Relative migraine pain relief at 2 hours post treatment as determined by difference of reported pain levels at the beginning and 2 hours after the end of electro stimulation session normalized by pain level on start of the session. Pain levels are assessed by means of Numerical Pain Scale.
次要结局
- Overall wellbeing as assessed by means of post-study questionnaire(6 months)
- Treatment related adverse effects, as assessed by means of post-study questionnaire, or participants' reports during the study.(6 months)
- Use of pain relief medications as assessed by participants' reports at follow-up.(6 months)
- Migraine attack duration as determined by time between reported onset of migraine attack and time when, for this attack, reported pain level drops by at least three levels. Pain levels are assessed by means of Visual Analog Scale .(2.5 hours)
- Number of migraine attacks per month as determined by the number of activations.(6 months)
- Migraine Relief at end of treatment as determined by difference of reported pain levels at the beginning of the electro stimulation and in the end of the electro stimulation session. Pain levels are assessed by means of NPS .(0.5 hours)