A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Percentage of Participants With Pain Relief 2 Hours Post Treatment
研究概览
简要总结
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
详细描述
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial "Migraine Treatment with Nerivio Migra electro stimulation device". The study will enroll up to 248 patients diagnosed with migraine with and without aura, per the inclusion and exclusion criteria. These patients will be individually and randomly assigned to either treatment group or control group. For sham control, short electrical pulses of amplitude range similar to that of the treatment programs will be administered at very low frequency (0.1-0.5 Hz). The rationale underlying selection of sham control settings is that, on the one hand, pulses are perceivable and the user is able to manipulate their intensity similarly to the case of treatment programs, while, on the other hand, no clinically relevant treatment is delivered, based on existing knowledge of parameters range of electro stimulation treatmentsץ
Following successful screening, enrollment interview and signing of informed consent, participants will be provided with an active Nerivio Migra or identically looking sham device and trained to perform treatment and provide feedback via the smartphone application. Ratio between treatment and control groups will be 1:1.
Baseline information including mean frequency and severity of migraine attacks, occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with and without aura and use of preventive and rescue medications will be recorded.
Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order to achieve the desired ratio between active and control groups sizes.
Stage One. In stage one (roll-in phase) recruited participants will be reporting their migraine attacks per ICHD-3 diagnostic criteria, including presence of aura, using an electronic migraine diary installed on their smartphones. Duration of this phase is one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patient is 18-75 years old.
- •Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
- •Patients reporting 2-8 migraine attacks per month.
- •Patient must be able and willing to comply with the protocol.
- •Patient must be able and willing to provide written informed consent.
- •Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study
排除标准
- •Has other significant pain problem that in the opinion of the investigator may confound the study assessments
- •Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
- •Known uncontrolled epilepsy.
- •Use of Cannabis including medical use.
- •Has chronic migraine (more than 15 headache days per month).
- •Changed usage or dosage of migraine preventive medications in the last two months
- •Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
- •Is participating in any other clinical study. -
结局指标
主要结局
Percentage of Participants With Pain Relief 2 Hours Post Treatment
时间窗: 2 hours post treatment
Percentage of participants reporting pain relief from pain (pain reduction from 3 or 2 to 1 or 0 or pain reduction from 1 to 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks
次要结局
未报告次要终点