nVNS for the Prevention and Treatment of Primary Headache
- Conditions
- Primary HeadacheMigraine in AdolescenceMigraine in ChildrenTension HeadacheCluster Headache
- Interventions
- Device: Transcutaneous auricular vagus nerve stimulationDevice: Sham transcutaneous auricular vagus nerve stimulation
- Registration Number
- NCT06277063
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.
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 attack and preventive 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 288
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute exacerbation experimental group Transcutaneous auricular vagus nerve stimulation 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. Acute exacerbation control group Sham transcutaneous auricular vagus nerve stimulation VAS pain intensity will be assessed at the onset of headache, and patients will receive sham-nVNS for half an hour within 20 minutes of the onset, and post-treatment evaluation results will be recorded immediately after intervention, 2 hours, 8-12 hours, 24 hours, and 36-48 hours. During the course of 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, 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. Seizure prevention experimental group Transcutaneous auricular vagus nerve stimulation The total course of intervention will be 8 weeks. Two 20-minute (5-10-5) closed-loop vagal - ECG/EMG measurements will be required before and after the intervention. Subjects will be required to keep a headache diary for 4 weeks at baseline before the intervention. The time of onset, duration, pain intensity (as measured by visual analogue scale (VAS)), accompanying symptoms, and medication use will be recorded. According to the randomized group, nVNS intervention will be carried out at home for 8 weeks, twice a day (7:00-8:00 in the morning and 19:00-20:00 in the evening). After the intervention, headache diary will be still needed to fill out, and the content will be the same as above. Headache diaries will be collected at 4-week intervals from week 4 to week 20. Seizure prevention control group Sham transcutaneous auricular vagus nerve stimulation The total course of intervention will be 8 weeks. Two 20-minute (5-10-5) closed-loop vagal - ECG/EMG measurements will be required before and after the intervention. Subjects will be required to keep a headache diary for 4 weeks at baseline before the intervention. The time of onset, duration, pain intensity (as measured by visual analogue scale (VAS)), accompanying symptoms, and medication use will be recorded. According to the randomized group, sham-nVNS intervention will be carried out at home for 8 weeks, twice a day (7:00-8:00 in the morning and 19:00-20:00 in the evening). After the intervention, headache diary will be still needed to fill out, and the content will be the same as above. Headache diaries will be collected at 4-week intervals from week 4 to week 20.
- Primary Outcome Measures
Name Time Method Reduction in pain intensity--actue period study 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.Reduction in the headache attack days during intervention--preventive period study 4 weeks of baseline, intervention period (5-12 weeks) and post-intervention period (13-20 weeks). 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 PP study, the primary outcome measure is the reduction in the headache attack days during intervention.
- Secondary Outcome Measures
Name Time Method Change in pain intensity--actue period study half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment For the AP study, we will analysis the change in pain intensity assessed by VAS scores, 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 A 20-minute closed-loop evaluation test of neck electromyography was performed before and after the intervention for both the AP study and PP study. The testing process consisted of 5 minutes of rest (i.e., no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes 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 A 20-minute closed-loop ECG assessment test was performed before and after the intervention for both the AP study and PP study. The test consisted of 5 minutes of rest (i.e., no vagal stimulation), 10 minutes of vagal stimulation, 5 minutes of rest, and a total of 20 minutes of electrocard.
Other outcomes for the preventive period study 4 weeks of baseline, intervention period (5-12 weeks) and post-intervention period (13-20 weeks). For the study subjects in the prevention period study, we will also collect data on the frequency of headaches and medication usage, and these, days of headache medication, mean headache intensity and mean headache duration, will be used as secondary outcome measures for the study.
Trial Locations
- Locations (1)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China