A Randomized, Single-Center, Double-Blind, Parallel, Sham-Controlled Study of Gammacore Sapphire (Non-Invasive Vagus Nerve Stimulator) for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Relief of Post Traumatic Headache
研究概览
简要总结
The purpose of this single-center, prospective, randomized, double-blind, sham controlled, parallel-group study is to collect clinical data related to the safety and efficacy of vagus nerve stimulation for the acute and preventive treatment of Post Traumatic Headache.
详细描述
The study will enroll 60 subjects over a period of 14 weeks each. Subjects will use either a sham or active device to treat acute Post Traumatic Headache. Investigators will collect clinical data related to the use of the device.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head
- •Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week
- •Presentation to clinic between 2 and 4 weeks after injury
- •Able to provide written informed consent
排除标准
- •Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache)
- •Any contraindication to using nVNS
- •Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study
- •Continuous headache at the time of enrollment
- •PTH >4 weeks after injury
- •Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
- •Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
- •Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that, in the opinion of the Investigator, may confound the study assessments
- •Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) or an abnormal baseline electrocardiogram (ECG) within the last year (e.g., second- or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
- •Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
- •Previous cervical vagotomy
- •A relative of or an employee of the Investigator or the clinical study site
- •Previously used gammaCore
结局指标
主要结局
Relief of Post Traumatic Headache
时间窗: Over 14 weeks
Decrease in pain between active and sham treatment groups between the baseline assessment and 60 minutes post-treatment on a subset of questions from the Sport Concussion Assessment Tool, 5th edition (SCAT5) Graded Symptom Checklist
次要结局
- Decrease in Pain(Over 14 weeks)