School of Psychology, University of Kent, Canterbury, UK.
School of Psychology, University of Kent, Canterbury, UK.
Parkinsonism Relat Disord. 2019 Aug;65:261-266. doi: 10.1016/j.parkreldis.2019.05.031. Epub 2019 May 31.
A recent case study showed that repeated sessions of caloric vestibular stimulation (CVS) relieved motor and non-motor symptoms associated with Parkinson's disease (PD). Here we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study.
33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n = 16) or placebo (n = 17) treatment period. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) 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 at 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.
Change scores between baseline and the end of treatment showed that active-arm subjects demonstrated clinically-relevant reductions in motor and non-motor symptoms that were significantly greater than placebo-arm subjects. Active treatment was also associated with improved scores on activities of daily living assessments. Therapeutic gains were still evident 5 weeks after the end of active treatment but had started to recede at 24 weeks follow-up. No serious adverse events were associated with device use, and there was high participant satisfaction and tolerability of treatment.
The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.
最近的一项病例研究表明，重复的温热前庭刺激（CVS）治疗可缓解帕金森病（PD）相关的运动和非运动症状。在此，我们旨在通过一项前瞻性、双盲、随机、安慰剂对照研究来验证这些结果。
33 名正在接受稳定抗帕金森病治疗的 PD 患者完成了活性（n=16）或安慰剂（n=17）治疗期。受试者在家中通过便携式、预编程的固态 ThermoNeuroModulation（TNM™）设备自行进行每日两次 CVS，该设备通过安装在可穿戴耳机上的铝制耳塞提供不断变化的热波形。在 4 周基线期、8 周治疗期后，以及治疗后 5 周和 24 周时对受试者进行随访。在每次研究访问时，在 ON 药物状态下进行标准化临床评估，以评估运动和非运动症状、日常生活活动和生活质量评分的变化。
从基线到治疗结束的变化评分显示，活性臂受试者表现出与临床相关的运动和非运动症状的显著降低，明显优于安慰剂臂受试者。积极治疗还与日常生活活动评估的评分改善相关。在积极治疗结束后 5 周，治疗效果仍然明显，但在 24 周随访时开始消退。与设备使用相关的严重不良事件并不常见，并且患者对治疗的满意度和耐受性很高。
这些结果提供了证据表明，重复的 CVS 可以为 PD 相关的运动和非运动症状提供安全且持久的辅助缓解。
