背景:慢性丛集性头痛(CCH)是一种使人衰弱的原发性头痛疾病。枕神经刺激(ONS)已显示出降低发作频率的潜力,但是常规(补品)刺激引起的枕骨感觉异常挑战了主动刺激和安慰剂的盲法比较。BurstONS提供无感觉异常的刺激,启用盲人,安慰剂对照研究。确定可行的术前测试将有助于选择最佳的植入候选者。本研究旨在探索ONS作为CCH的预防性治疗方法,将爆发刺激与补品刺激和安慰剂进行比较,并可能确定潜在的术前预测因子。
方法:研究者发起,双盲,随机化,进行安慰剂对照试验,包括40名CCH患者。符合条件的患者完成以下要素的试验:I)四周的基线观察,II)枕骨神经经皮电刺激(TENS)12周,III)植入完整的ONS系统,然后是2周的宽限期,IV)进行12周的盲法试验,1:1随机分配给安慰剂(停用的ONS系统)或爆发(无感觉异常)刺激,和V)12周的补品刺激。主要结果是TENS和ONS的头痛发作频率降低以及治疗安全性。次要结果是突发ONS与强直ONS的治疗效果,TENS作为ONS结果预测指标的可行性,头痛疼痛强度降低(数字评定量表),减少背景头痛,患者的改变印象(PGIC),健康相关生活质量(EuroQoL-5D),自我报告的睡眠质量,以及焦虑和抑郁症状(医院焦虑和抑郁量表,HADS)。每周记录有关头痛发作特征的数据。在每个试验阶段后评估患者报告结果的数据。
结论:研究设计允许在难治性CCH中比较爆发ONS和安慰剂,并能够比较爆发和强直ONS的疗效。它将提供有关爆发ONS的影响的信息,并探讨这种刺激范例的添加是否可以改善刺激方案。通过比较TENS和强直ONS的发作预防效果,将TENS评估为ONS结局的可行术前筛查工具。
背景:该研究在Clinicaltrials.gov注册(试验注册编号NCT05023460,注册日期07-27-2023)。
BACKGROUND: Chronic cluster headache (CCH) is a debilitating primary headache disorder. Occipital nerve stimulation (ONS) has shown the potential to reduce attack frequency, but the occipital paresthesia evoked by conventional (tonic) stimulation challenges a blinded comparison of active stimulation and placebo. Burst ONS offers paresthesia-free stimulation, enabling a blinded, placebo-controlled study. Identification of a feasible preoperative test would help select the best candidates for implantation. This study aims to explore ONS as a preventive treatment for CCH, comparing burst stimulation to tonic stimulation and placebo, and possibly identifying a potential preoperative predictor.
METHODS: An investigator-initiated, double-blinded, randomized, placebo-controlled trial is conducted, including 40 patients with CCH. Eligible patients complete a trial with the following elements: I) four weeks of baseline observation, II) 12 weeks of transcutaneous electrical nerve stimulation (TENS) of the occipital nerves, III) implantation of a full ONS system followed by 2 week grace period, IV) 12 weeks of blinded trial with 1:1 randomization to either placebo (deactivated ONS system) or burst (paresthesia-free) stimulation, and V) 12 weeks of tonic stimulation. The primary outcomes are the reduction in headache attack frequency with TENS and ONS and treatment safety. Secondary outcomes are treatment efficacy of burst versus tonic ONS, the feasibility of TENS as a predictor for ONS outcome, reduction in headache pain intensity (numeric rating scale), reduction in background headache, the patient\'s impression of change (PGIC), health-related quality of life (EuroQoL-5D), self-reported sleep quality, and symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, HADS). Data on headache attack characteristics are registered weekly. Data on patient-reported outcomes are assessed after each trial phase.
CONCLUSIONS: The study design allows a comparison between burst ONS and placebo in refractory CCH and enables a comparison of the efficacy of burst and tonic ONS. It will provide information about the effect of burst ONS and explore whether the addition of this stimulation paradigm may improve stimulation protocols. TENS is evaluated as a feasible preoperative screening tool for ONS outcomes by comparing the effect of attack prevention of TENS and tonic ONS.
BACKGROUND: The study is registered at Clinicaltrials.gov (trial registration number NCT05023460, registration date 07-27-2023).