Bogan Sleep Consultants, LLC, Columbia, SC, USA.
Ohio Sleep Medicine Institute, Dublin, OH, USA.
Sleep. 2023 Oct 11;46(10). doi: 10.1093/sleep/zsad190.
The purpose of this study was to evaluate the efficacy and safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in patients with medication-refractory restless legs syndrome (RLS).
RESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in adults with medication-refractory moderate-to-severe primary RLS. Participants were randomized 1:1 to active or sham TOMAC for a double-blind, 4-week stage 1 and all received active TOMAC during open-label, 4-week stage 2. The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at the end of stage 1. Key secondary endpoints included change to International RLS Study Group (IRLS) total score from study entry to the end of stage 1.
A total of 133 participants were enrolled. CGI-I responder rate at the end of stage 1 was significantly greater for the active versus sham group (45% vs. 16%; Difference = 28%; 95% CI 14% to 43%; p = .00011). At the end of stage 2, CGI-I responder rate further increased to 61% for the active group. IRLS change at the end of stage 1 improved for the active versus sham group (-7.2 vs. -3.8; difference = -3.4; 95% CI -1.4 to -5.4; p = .00093). There were no severe or serious device-related adverse events (AEs). The most common AEs were mild discomfort and mild administration site irritation which resolved rapidly and reduced in prevalence over time.
TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population.
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study); clinicaltrials.gov/ct2/show/NCT04874155; Registered at ClinicalTrials.gov with the identifier number NCT04874155.
本研究旨在评估双侧高频紧张性运动激活（TOMAC）治疗药物难治性不安腿综合征（RLS）患者的疗效和安全性/耐受性。
RESTFUL 是一项多中心、随机、双盲、假对照试验，纳入了药物难治性中重度原发性 RLS 成年患者。患者按 1:1 随机分配至真 TOMAC 或假 TOMAC 治疗，进行为期 4 周的双盲第 1 阶段，所有患者在 4 周的开放标签第 2 阶段均接受真 TOMAC 治疗。主要终点为第 1 阶段结束时临床总体印象改善（CGI-I）应答率。次要终点包括从研究入组到第 1 阶段结束时国际 RLS 研究组（IRLS）总分的变化。
共纳入 133 名患者。第 1 阶段结束时，真 TOMAC 组的 CGI-I 应答率显著高于假 TOMAC 组（45%比 16%；差值=28%；95%CI 14%至 43%；p=.00011）。第 2 阶段结束时，真 TOMAC 组的 CGI-I 应答率进一步增加至 61%。第 1 阶段结束时，真 TOMAC 组的 IRLS 评分改善（-7.2 比-3.8；差值=-3.4；95%CI -1.4 至 -5.4；p=.00093）。无严重或严重的设备相关不良事件（AE）。最常见的 AE 为轻度不适和轻度给药部位刺激，这些 AE 迅速缓解，且随时间推移其发生率降低。
TOMAC 安全且耐受良好，可减轻药物难治性 RLS 患者的症状。TOMAC 是该人群有前景的新治疗方法。
非侵入性周围神经刺激治疗药物难治性原发性 RLS（RESTFUL 研究）；clinicaltrials.gov/ct2/show/NCT04874155；在 ClinicalTrials.gov 注册，标识符为 NCT04874155。
