Hartley Sarah, Bao Guillaume, Zagdoun Marine, Chevallier Sylvain, Lofaso Frédéric, Leotard Antoine, Azabou Eric
Sleep Unit, Department of Physiology, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris, Garches, Paris, France.
Clinical Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris, Garches, Paris, France; Laboratory of Infection and Inflammation Inserm UMR 1173, University of Versailles Saint-Quentin en Yvelines, Paris-Saclay University, Paris, France.
Neuromodulation. 2023 Apr;26(3):629-637. doi: 10.1016/j.neurom.2022.10.046. Epub 2022 Nov 16.
This work aimed to study the effect of noninvasive vagus nerve stimulation on severe restless legs syndrome (RLS) resistant to pharmacotherapy.
Patients with severe pharmacoresistant RLS were recruited from a tertiary care sleep center. Intervention was one-hour weekly sessions of transauricular vagus nerve stimulation (tVNS) in the left cymba concha, for eight weeks. The primary outcome measure was the score on the International Restless Legs Rating Scale (IRLS); secondary outcome measures were quality of life (Restless Legs Syndrome Quality of Life scale [RLSQOL]), mood disorders using the Hospital Anxiety and Depression scale subscale for depression (HADD) and Hospital Anxiety and Depression scale subscale for anxiety (HADA), and objective sleep latency, sleep duration, efficiency, and leg movement time measured by actigraphy.
Fifteen patients, 53% male, aged mean 62.7 ± 12.3 years with severe RLS, reduced quality of life, and symptoms of anxiety and depression, were included. The IRLS improved from baseline to session eight: IRLS 31.9 ± 2.9 vs 24.6 ± 5.9 p = 0.0003. Of these participants, 27% (4/15) had a total response with a decrease below an IRLS score of 20; 40% (6/15) a partial response with an improvement in the IRLS > 5 but an IRLS above 20; and 33% (5/15) were nonresponders. After tVNS, quality of life improved (RLSQOL 49.3 ± 18.1 vs 80.0 ± 19.6 p = 0.0005), as did anxiety (HADA 8.9 ± 5.4 vs 6.2 ± 5.0 p = 0.001) and depression (HADD 5.2 ± 4.5 vs 4.0 ± 4.0 p = 0.01). No significant change was found in actigraphic outcome measures.
In this pilot study, tVNS improved the symptoms of RLS in 66% of participants (10/15) with severe pharmacoresistant RLS, with concomitant improvements in quality of life and mood. Randomized controlled trials evaluating therapeutic efficacy of tVNS in RLS are needed to confirm these promising findings.
本研究旨在探讨无创迷走神经刺激对药物治疗无效的严重不安腿综合征（RLS）的影响。
从一家三级医疗睡眠中心招募药物治疗无效的严重RLS患者。干预措施为每周一次，每次一小时，在左耳甲腔进行经耳迷走神经刺激（tVNS），共持续八周。主要结局指标为国际不安腿评分量表（IRLS）得分；次要结局指标包括生活质量（不安腿综合征生活质量量表[RLSQOL]）、使用医院焦虑抑郁量表抑郁分量表（HADD）和医院焦虑抑郁量表焦虑分量表（HADA）评估的情绪障碍，以及通过活动记录仪测量的客观睡眠潜伏期、睡眠时间、睡眠效率和腿部运动时间。
纳入15例患者，男性占53%，平均年龄62.7±12.3岁，患有严重RLS、生活质量下降以及焦虑和抑郁症状。从基线到第八次治疗，IRLS有所改善：IRLS从31.9±2.9降至24.6±5.9，p = 0.0003。在这些参与者中，27%（4/15）完全缓解，IRLS得分降至20以下；40%（6/15）部分缓解，IRLS改善超过5分但仍高于20分；33%（5/15）无反应。tVNS治疗后，生活质量得到改善（RLSQOL从49.3±18.1提高到80.0±19.6，p = 0.0005），焦虑（HADA从8.9±5.4降至6.2±5.0，p = 0.001）和抑郁（HADD从5.2±4.5降至4.0±4.0，p = 0.01）也有所改善。活动记录仪测量的结局指标未发现显著变化。
在这项初步研究中，tVNS使66%（10/15）药物治疗无效的严重RLS患者的症状得到改善，同时生活质量和情绪也有所改善。需要进行随机对照试验来评估tVNS对RLS的治疗效果，以证实这些有前景的发现。
