nVNS for the Prevention and Treatment of Primary Headache

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

Conditions: Migraine in Adolescence; Tension Headache; Primary Headache; Migraine in Children; Cluster Headache

Treatments: Device: Transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06277063

NFEC-2024-057

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 7 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Age >=7 years old, <=20 years old;
3. Patients have experienced headache on 3-15 days per month in the past;
4. Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
5. They volunteered to participate in the trial and signed informed consent.

Exclusion criteria

1. History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
2. prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
3. Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
4. An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
5. underwent head and neck nerve block within the past 2 months;
6. 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);
7. Patients who underwent cervical vagotomy (cervical vagotomy);
8. Pediatric patients (under 6 years old); Pregnant women;
9. Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
10. Patients with congenital heart disease;
11. Mental/cognitive disorders, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 4 patient groups

Acute exacerbation experimental group

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation

Acute exacerbation control group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham transcutaneous auricular vagus nerve stimulation

Seizure prevention experimental group

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation

Seizure prevention control group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham transcutaneous auricular vagus nerve stimulation