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临床试验/NCT03471923
NCT03471923已完成不适用

Non-Motor Features of Cervical Dystonia

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Prevalence of vibration-induced illusion of movement in cervical dystonia patients, unaffected family members, and healthy volunteers

研究概览

简要总结

This study will examine the prevalence of four previously identified non-motor markers in a population of cervical dystonia patients, unaffected family members, and healthy volunteers in an attempt to identify a distinct combination of non-motor symptoms that may be indicative of disease development.

详细描述

The primary aim of this study is to identify the prevalence of four previously identified non-motor markers - (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia - in a population of cervical dystonia patients, unaffected family members, and healthy volunteers (control group). Consenting participants will receive a neurological examination performed by a movement disorders neurologist, followed by an assessment of the four non-motor symptoms.

The investigators hypothesize that a distinct combination of non-motor symptoms will be more prevalent in the CD group, and therefore this set of symptoms may be indicative of disease development. This combination will be identified through analysis of the concurrence of the non-motor features across the three groups of participants. This study will fill an important unmet need, as to the investigators' knowledge there are no published studies assessing the comorbid presentation of these four non-motor symptoms in a single cervical dystonia population. The exploration of a distinct combination of concurrent non-motor symptoms as a marker for the development of cervical dystonia will improve the ability of movement disorders neurologists to diagnose the condition.

The results of this study will facilitate the investigators' longstanding aim of improving rates of cervical dystonia diagnosis. Cervical dystonia is currently diagnosed based upon the exclusion of other movement disorders; therefore, characterization of non-motor features in cervical dystonia patients will help to refine the diagnostic criteria for this condition. This investigation will also improve understanding of the factors associated with CD. Future studies can examine the source of these associated factors in order to help understand the cause of CD, since the etiology is currently unknown.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a diagnosis of cervical dystonia, OR a first order relation of a Vanderbilt patient diagnosed with cervical dystonia, OR a healthy volunteer who is neurologically normal
  • Capable of participating in all study procedures
  • Willing and able to provide written or verbal informed consent.

排除标准

  • Subjects for whom participation in the study may cause medical harm
  • Subjects who are not considered competent to make their own medical decisions
  • Subjects who display sensory deficits during a short screening examination prior to study enrollment

结局指标

主要结局

Prevalence of vibration-induced illusion of movement in cervical dystonia patients, unaffected family members, and healthy volunteers

时间窗: Up to 6 months after consent is obtained

For participants in all groups, the investigators will examine the prevalence of vibration-induced illusion of movement. Prevalence of vibration-induced illusion of movement will be determined by recording the change in displacement of the tracking arm during a vibration-induced illusion of movement task. The research coordinator will report prevalence of vibration-induced illusion of movement as a descriptive statistic.

Prevalence of impaired kinesthesia in cervical dystonia

时间窗: Up to 6 months after consent is obtained

For participants in all groups, the investigators will examine the prevalence of impaired kinesthesia. Kinesthesia will be determined by a neurologist during the neurological examination. The research coordinator will report prevalence of impaired kinesthesia as a descriptive statistic.

Prevalence of spatial discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers

时间窗: Up to 6 months after consent is obtained

For participants in all groups, the investigators will examine the prevalence of spatial discrimination threshold. Prevalence of spatial discrimination threshold will be determined with a task using Johnson-Van-Boven-Phillips (JVP) domes. The spatial discrimination threshold will be recorded as the mean of both hands at the 75% level of accuracy. The research coordinator will report prevalence of spatial discrimination threshold as a descriptive statistic.

Prevalence of temporal discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers

时间窗: Up to 6 months after consent is obtained

For participants in all groups, the investigators will examine the prevalence of temporal discrimination threshold. Prevalence of temporal discrimination threshold will be determined with a visual-visual discrimination task.The research coordinator will report prevalence of temporal discrimination threshold as a descriptive statistic.

次要结局

  • Probability of concurrence of multiple non-motor features(Up to 6 months after consent is obtained)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mallory Hacker

Research Instructor

Vanderbilt University Medical Center

研究点 (1)

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