nVNS for the Prevention and Treatment of Primary Headache

Официальное название

Noninvasive Vagus Nerve Stimulation for the Prevention and Treatment of Primary Headache: a Single-arm Single-center Clinical Trial.

Обзор

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.

Вмешательства

• Устройство Transcutaneous auricular vagus nerve stimulation
  The vagus nerve's auricular branch is primarily distributed in the tragus, tragus sulcus, and concha cavity. It can activate the nucleus tractus solitarius through the vagus afferent fibers, thereby activating various areas of the vagus nerve in the central nervous system. This stimulation technique involves applying a constant current of around 2-3mA to the epidermal terminals of the ear using an electrode. It aims to regulate the vagus nerve, modulate the autonomic nervous system, release neur

Первичные конечные точки

• Reduction in pain intensity--actue period study [Срок оценки: 2 hours after treatment]

Вторичные конечные точки (3)

• Heart rate variability(HRV)--actue period study and preventive period study [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: half hour, 8-12 hours, 24 hours, and 36-48 hours after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital, Southern Medical University — Гуанчжоу

Публикации

• Martelletti P, Barbanti P, Grazzi L, Pierangeli G, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Tassorelli C, Liebler E, de Tommaso M; PRESTO Study Group. Correction to: Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Dec 18;19(1):12 PMID 30563446
• Diener HC, Goadsby PJ, Ashina M, Al-Karagholi MA, Sinclair A, Mitsikostas D, Magis D, Pozo-Rosich P, Irimia Sieira P, Lainez MJ, Gaul C, Silver N, Hoffmann J, Marin J, Liebler E, Ferrari MD. Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial. Cephalalgia. 2019 Oct;39(12):1475-1487. PMID 31522546
• Cao J, Zhang Y, Li H, Yan Z, Liu X, Hou X, Chen W, Hodges S, Kong J, Liu B. Different modulation effects of 1 Hz and 20 Hz transcutaneous auricular vagus nerve stimulation on the functional connectivity of the periaqueductal gray in patients with migraine. J Transl Med. 2021 Aug 17;19(1):354. doi: 10.1186/s12967-021-03024-9. PMID 34404427
• Lai YH, Huang YC, Huang LT, Chen RM, Chen C. Cervical Noninvasive Vagus Nerve Stimulation for Migraine and Cluster Headache: A Systematic Review and Meta-Analysis. Neuromodulation. 2020 Aug;23(6):721-731. doi: 10.1111/ner.13122. Epub 2020 Mar 12. PMID 32166843
• Weng S, Xiao X, Liang S, Xue Y, Yang X, Ji Y. Single-centre, randomised and double-blind clinical trial on the efficacy of transcutaneous auricular vagus nerve stimulation in preventing and treating primary headache in children and adolescents: a study protocol. BMJ Open. 2025 Mar 12;15(3):e092692. doi: 10.1136/bmjopen-2024-092692. PMID 40074270

Идентификаторы

NCT: NCT06277063 · NFEC-2024-057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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