Noninvasive Vagus Nerve Stimulation for the Prevention and Treatment of Primary Headache: a Single-arm Single-center Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in pain intensity--actue period study
研究概览
简要总结
This study is a single-center, single-arm study. All subjects will receive the same treatment.
Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation.
Therefore, this study will verify the effect of nVNS on the acute treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with migraine, cluster headache and tension-type headache were diagnosed according to Chinese Guidelines for the diagnosis and Treatment of Migraine (2022 edition) and Chinese Guidelines for the diagnosis and treatment of cluster headache (2022 edition).
- •Age >=7 years old, <=20 years old;
- •Patients have experienced headache on 3-15 days per month in the past;
- •Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
- •They volunteered to participate in the trial and signed informed consent.
排除标准
- •History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
- •prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
- •Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
- •An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
- •underwent head and neck nerve block within the past 2 months;
- •Opioid use (more than 2 days per month); Use of analgesics alone or non-steroidal anti-inflammatory drugs (more than 15 days per month); Or tamoxifen, ergots or combination analgesics (more than 10 days per month);
- •Patients who underwent cervical vagotomy (cervical vagotomy);
- •Pediatric patients (under 6 years old); Pregnant women;
- •Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
- •Patients with congenital heart disease;
- •Mental/cognitive disorders, etc.
研究组 & 干预措施
Acute exacerbation experimental group
VAS pain intensity will be assessed at the onset of headache, and patients will receive nVNS for half an hour within 20 minutes of the onset, and post-treatment evaluation results will be recorded immediately after treatment, 2 hours, 8-12 hours, 24 hours, and 36-48 hours. During the course of treatment and intervention, a 20-minute ECG closed-loop assessment test will be performed before admission and after return. The procedure included: 5 minutes of rest (i.e. no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes of rest(5-10-5), a total of 20 minutes of ECG, and real-time extraction of heart rate and sex data. Neck electromyography before and after intervention was also used as an auxiliary indicator.
干预措施: Transcutaneous auricular vagus nerve stimulation (Device)
结局指标
主要结局
Reduction in pain intensity--actue period study
时间窗: 2 hours after treatment
The visual analogue scale (VAS) was used to evaluate the pain. It is widely used in clinical practice in China. The basic method is to use a swimming ruler of about 10cm in length, marked with 10 scales on one side, and "0" and "10" scales on both ends. For the AP study, the primary outcome measure is the reduction in pain intensity assessed by VAS 2 hours after treatment.
次要结局
- Change in pain intensity--actue period study(half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment)
- Electromyography(EMG)--actue period study and preventive period study(before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard)
- Heart rate variability(HRV)--actue period study and preventive period study(before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard)
- Electromyography(EMG)--actue period study and preventive period study(before and after the intervention. The test consisted of 5 mins of rest (i.e., no vagal stimulation), 10 mins of vagal stimulation, 5 mins of rest, and a total of 20 minutes of electrocard)
- Change in pain intensity--actue period study(half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment)