nVNS for the Prevention and Treatment of Primary Headache

Not Applicable

Not yet recruiting

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

• 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

Study Timeline

• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-26
• Status Verified: 2024-12
• Study Start: 2024-12-05
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 288

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China