Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson's disease

Here we report the clinical and demographic data from a single site clinical trial which sought to evaluate the potential efficacy of caloric vestibular stimulation (CVS) treatment for symptoms associated with Parkinson's disease (PD). 46 PD subjects on stable anti-Parkinsonian medications were randomized to received either active or placebo treatments. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Subjects were followed over a 4-week baseline period, 8 weeks of treatment and then 5- and 24-weeks post-treatment At each study visit, standardized clinical assessments were conducted during ON-medication states to evaluate changes in motor and non-motor symptoms, activities of daily living and quality of life ratings. For additional interpretation, see Wilkinson et al., 2019 "Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson's disease" (https://doi.org/10.1016/j.parkreldis.2019.05.031).本研究报道了一项单中心临床试验的临床及人口统计学数据，该试验旨在评估热量前庭刺激（caloric vestibular stimulation, CVS）疗法对帕金森病（Parkinson's disease, PD）相关症状的潜在疗效。本研究共纳入46名服用稳定剂量抗帕金森病药物的PD受试者，将其随机分配至活性治疗组或安慰剂对照组。受试者每日两次在家自行通过便携式预编程固态热神经调控设备（ThermoNeuroModulation device）完成CVS治疗：该设备通过搭载于可穿戴头带的铝制耳探头输出持续变化的热波形。研究随访周期涵盖4周基线期、8周治疗期，以及治疗后5周和24周两个随访节点。在每次研究访视中，均于受试者服药开启状态（ON-medication states）下开展标准化临床评估，以评估运动症状、非运动症状、日常生活活动能力及生活质量评分的变化情况。如需进一步解读相关结果，可参阅Wilkinson等人2019年发表的《热量前庭刺激用于帕金森病运动与非运动症状的管理》一文（https://doi.org/10.1016/j.parkreldis.2019.05.031）。