Wilkinson David, Podlewska Aleksandra, Banducci Sarah E, Pellat-Higgins Tracy, Slade Martin, Bodani Mayur, Sakel Mohamed, Smith Lanty, LeWitt Peter, Ade Kristen
School of Psychology, University of Kent, Canterbury, UK.
Scion NeuroStim, LLC, Durham, NC, USA.
Data Brief. 2019 Jul 8;25:104228. doi: 10.1016/j.dib.2019.104228. eCollection 2019 Aug.
This report provides data related to the safety and effectiveness of repeated time-varying caloric vestibular stimulation (CVS) as a treatment for motor and non-motor features of Parkinson's disease (PD). Forty-six subjects receiving stable anti-Parkinsonian therapy were randomized to active (n = 23) or placebo (n = 23) treatment arms. Subjects self-administered CVS twice-daily over a period of 8 weeks at home via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device delivering continually-varying thermal waveforms through aluminium ear-probes mounted on a wearable headset. Change scores from baseline to end of treatment and to a 1-month follow-up were determined using standardized clinical measures. The data presented here report sample demographics, detailed safety data and the statistical outcomes from the intention-to-treat and modified intention-to-treat analyses. .
本报告提供了有关重复时变热量前庭刺激（CVS）作为帕金森病（PD）运动和非运动特征治疗方法的安全性和有效性的数据。46名接受稳定抗帕金森病治疗的受试者被随机分为活性治疗组（n = 23）或安慰剂治疗组（n = 23）。受试者在家中通过便携式、预编程的固态热神经调制（TNM™）设备，每天自行进行两次CVS治疗，持续8周，该设备通过安装在可穿戴头带上的铝制耳探头传递不断变化的热波形。使用标准化临床测量方法确定从基线到治疗结束以及到1个月随访的变化分数。此处呈现的数据报告了样本人口统计学、详细的安全性数据以及意向性治疗和改良意向性治疗分析的统计结果。
