跳至主要内容
临床试验/NCT03432338
NCT03432338已完成不适用

Distribution of Non-Motor Symptoms in Idiopathic Parkinson's Disease and Secondary Parkinsonism A Controlled, Descriptive Cross-sectional Study Using Parkinson's Well-Being Map™

Örjan Skogar0 个研究点目标入组 208 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
208
主要终点
Prevalence of selfreported motor and non-motor symptoms with The Parkinson´s Well-being map

研究概览

简要总结

BACKGROUND:

Non-Motor Symptoms (NMS) are frequent in patients with Idiopathic Parkinson's Disease (IPD). Clinical expressions, postulated pathophysiological mechanisms and responsiveness to antiparkinson medication represent differences between IPD and secondary Parkinsonism (SP).

OBJECTIVES:

To evaluate NMS expressions in IPD, SP and a control group.

METHODS:

Diagnosis of SP was supported by comorbidity, radiological findings, type of onset, onset rate and progression, exposures for neuroleptics, and responsiveness to pharmacological antiparkinson therapy.

The participants were consecutively recruited at two outdoor patient clinics. The Well-Being Map™ for evaluation. These were completed by the participants at one point before visit. The controls consisted of non-Parkinsonian individuals, matched by age and gender.

详细描述

Over the past decades knowledge of the natural history and progression of Parkinson´s disease (PD) has increased. Age at onset, time to troublesome complications are well described. Parallell to this, the society has been more and more aware of differences between gender in the expressions of diseases. Differences in self reported experiences are of great interest as this is tightly interconnected with Health Related Quality of Life, (HRQoL).

The incidence of PD rapidly increase over the age of 60 years (y) , with only 4% of the cases being under the age of 50 y. The rate for men 19.0 per 100,000, was 91% higher than that for women (9.9 per 100,000 )The age- and gender-adjusted rate per 100,000 was highest among Hispanics (16.6,non-Hispanic Whites ,Asians (11.3, and Blacks (10.2). These data suggest that the incidence of Parkinson's disease varies by race/ethnicity.

( ref. Van den Eeden 2003)

Nonmotor Symptoms in Parkinson's Disease:

Of the nine domains in the validated NMSS (Chaudhuri, Martinez- Martin, Brown, et al., 2007), sexual dysfunction and mood changes have been commonly observed to have associations with specific gender. While sexual dysfunction has been commonly reported with a significantly higher proportion among men (Kova ́cs, Makkos, Aschermann, et al., 2016; Martinez-Martin, Falup Pecurariu, Odin, et al., 2012; Picillo, Amboni, Erro, et al., 2013; Solla, Cannas, Ibba, et al., 2012; Szewczyk- Krolikowski, Tomlinson, Nithi, et al., 2014), mood symptoms, which encompass loss of interest in surroundings, lack of motivation, feeling ner- vous, flat mood, and difficulty in experiencing pleasure, have been frequently reported among women in a higher proportion compared to men with PD (Guo, Song, Chen, et al., 2013; Martinez-Martin et al., 2012; Nicoletti, Vasta, Mostile, et al., 2017; Solla et al., 2012; Song, Gu, An, & Chan, 2014).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • " Clinical diagnosis of Idiopathic Parkinson´s Disease " Clinical diagnosos of secondary parkinsonism " Healthy controls " Age >65 years " >1 year duration of disease after diagnose

排除标准

  • " Participation in other studies " Severe disease of psychiatric origin " Severe cognitive impairment

结局指标

主要结局

Prevalence of selfreported motor and non-motor symptoms with The Parkinson´s Well-being map

时间窗: 12 months

A graded check list presented in The Parkinson´s Well-BeingMap is used in the registration of self reported frequencies and self experienced strength of Motor and Non- Motor Symptoms in two different forms of parkinsonism and in a group of healthy controls.The experienced magnitude of suffering is visualized in a spider diagram reflecting the strength of each item on an ordinal scale from 0 to four. Primary outcome measure is to compare reported frequencies between groups.

次要结局

  • Prevalence of combinations of reported motor and non-motor symptoms using(12 months)

研究者

发起方
Örjan Skogar
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Örjan Skogar

MD,PhD

Region Jönköping County

相似试验