A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity.
A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity.
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DOI：
10.1136/bmjopen-2017-016843
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发表时间：
2017-09-07
期刊：
影响因子：
2.9
通讯作者：
Trompetto C
中科院分区：
文献类型：
--
作者：
Marinelli L;Balestrino M;Mori L;Puce L;Rosa GM;Giorello L;Currà A;Fattapposta F;Serrati C;Gandolfo C;Abbruzzese G;Trompetto C
中风是最致残的神经系统疾病，往往会导致痉挛。大麻素（四氢大麻酚和大麻二酚（THC：CBD），Sativex）目前可用于治疗多发性硬化症患者的痉挛相关症状。大麻素被认为也可用于治疗疼痛、恶心和癫痫，但可能会增加心血管事件的风险。痉挛状态通常用主观和临床评定量表进行评估，这些量表无法测量被认为是痉挛状态标志的单突触反射的兴奋性增加。牵张反射的神经生理学评估提供了一种精确和客观的方法来测量痉挛。我们提出了一项新的研究，以了解Sativex是否有助于减少中风幸存者的痉挛，并通过准确的心血管监测研究耐受性和安全性。我们将招募50名中风后痉挛患者，在一项双盲安慰剂对照交叉研究中服用THC：CBD。将使用痉挛的数字评定量表、改良Ashworth量表和牵张反射的肌电图记录评估痉挛。入选前将评估心血管风险。整个研究期间将监测血压、心率、每日痉挛次数、膀胱功能、睡眠中断和不良事件。将使用混合模型方差分析比较时间点之间的牵张反射幅度;将使用Mann-Whitney检验（THC：CBD vs安慰剂）和Wilcoxon检验（基线vs治疗）比较半定量测量。该研究在EudraCT数据库中注册，编号为2016-001034-10，并获得意大利药品管理局（意大利药品管理局）和当地伦理委员会“Comitato Etico Regionale della Liguria”的批准。数据将被匿名并上传到一个开放获取的储存库。研究结果将通过在国家和国际会议上的演讲以及在临床神经科学和神经病学杂志上的出版物进行传播。
Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring. We will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment). The study was registered on the EudraCT database with number 2016-001034-10 and approved by both the Italian Medicines Agency (Agenzia Italiana del Farmaco) and local Ethics Committee ‘Comitato Etico Regionale della Liguria’. Data will be made anonymous and uploaded to a open access repository. Results will be disseminated by presentations at national and international conferences and by publication in journals of clinical neuroscience and neurology.
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影响因子：
4.6
作者：
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Montecucco F
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