Department of Neurosurgery, University Hospital of Ioannina, Ioannina, Greece.
Department of Neurosurgery, University Hospital of Ioannina, Ioannina, Greece.
Seizure. 2021 Oct;91:40-48. doi: 10.1016/j.seizure.2021.05.017. Epub 2021 May 24.
Transcutaneous auricular vagus nerve stimulation (t-VNS) has been proposed as an alternative method for the treatment of various neurological and psychiatric disorders. Contrary to the classic invasive vagus nerve stimulation (i-VNS), t-VNS does not require surgical intervention. The application of t-VNS for the treatment of epilepsy has been poorly studied. Hence, we performed a systematic review of the literature to elucidate efficacy, adverse effects and technical features of t-VNS in patients with epilepsy.
We systematically searched MEDLINE and SCOPUS databases using the following keywords: [TRANSCUTANEOUS VAGUS NERVE STIMULATION OR TRANSCUTANEOUS VAGAL NERVE STIMULATION] AND [EPILEPSY OR SEIZURES]. We searched for observational studies in English concerning the application of t-VNS for the treatment of epilepsy in humans. The full-text version of relevant studies was obtained and reviewed. Technical parameters of the stimulation, percentage of seizure frequency reduction, QOLIE-31(Quality of Life In Epilepsy-31) and LSSS (Liverpool Seizure Severity Scale) questionnaires and adverse effects were recorded and analyzed.
A total of 10 studies with 350 patients were included. Both bilateral and unilateral placement of the electrode were applied. Stimulation frequency varied from 10-30Hz, while treatment intensity was usually adjusted according to patients' preferences and tolerance (around 1mA) and below the pain threshold. In the clinical trials included in our review, the mean seizure frequency reduction varied from 30 to 65%. Eight and four studies provided information about QOLIE-31 and LSSS questionnaires respectively. Three studies reported a statistically significant (p<0,05) improvement in patients' quality of life and two studies reported statistically significant (p<0,05) seizure severity reduction. The most common side effect was headache (8,9%), followed by skin irritation at the placement site (7,1%) and nasopharyngitis (5,1%). No serious or life-threatening side effects were reported.
Due to the heterogeneity of the included studies, no safe conclusions could be extracted concerning the efficacy of t-VNS. However, the results of this review suggest that patients with epilepsy could possibly benefit from the use of t-VNS. The present study also emphasizes the limitations of previous clinical trials concerning the applications of t-VNS in people with epilepsy and thus could be a guidance for the conduction of future trials.
经皮耳迷走神经刺激(t-VNS)已被提议作为治疗各种神经和精神疾病的替代方法。与经典的侵入性迷走神经刺激(i-VNS)不同,t-VNS不需要手术干预。t-VNS 治疗癫痫的应用研究甚少。因此,我们对文献进行了系统回顾,以阐明 t-VNS 治疗癫痫患者的疗效、不良反应和技术特点。
我们使用以下关键词在 MEDLINE 和 SCOPUS 数据库中进行系统检索:[经皮迷走神经刺激或经皮迷走神经刺激]和[癫痫或发作]。我们搜索了关于 t-VNS 治疗人类癫痫的应用的英语观察性研究。获取并审查了相关研究的全文。记录和分析了刺激的技术参数、癫痫发作频率降低的百分比、QOLIE-31(癫痫生活质量 31 项)和 LSSS(利物浦癫痫严重程度量表)问卷以及不良反应。
共纳入 10 项研究,共计 350 例患者。研究中应用了双侧和单侧电极放置。刺激频率从 10-30Hz 不等,而治疗强度通常根据患者的喜好和耐受性(约 1mA)以及低于疼痛阈值进行调整。在我们的综述中纳入的临床试验中,平均癫痫发作频率降低幅度从 30%到 65%不等。有 8 项和 4 项研究分别提供了关于 QOLIE-31 和 LSSS 问卷的信息。有 3 项研究报告患者生活质量有统计学意义的(p<0.05)改善,有 2 项研究报告癫痫严重程度有统计学意义的(p<0.05)降低。最常见的不良反应是头痛(8.9%),其次是放置部位皮肤刺激(7.1%)和鼻咽部感染(5.1%)。没有报告严重或危及生命的不良反应。
由于纳入研究的异质性,无法就 t-VNS 的疗效得出安全结论。然而,本综述的结果表明,癫痫患者可能受益于 t-VNS 的应用。本研究还强调了之前临床试验在 t-VNS 应用于癫痫患者方面的局限性,可为未来试验提供指导。