Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,265
- 试验地点
- 42
- 主要终点
- Observational
研究概览
简要总结
Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.
详细描述
This collaborative, international effort has one primary goal. This is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. Across sites, the investigators hope to enroll at least 5,000 adult patients.
Subjects of this study will be asked to complete a neurological exam which will be video recorded, complete some questionnaires, and donate a blood sample. A study visit will take between 45 minutes and 1 hour. All subjects will be asked to return every 1, 2, 3, or 4 years for a one hour follow-up visit. People may participate in this study without agreeing to participate in the follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with isolated dystonia or myoclonus dystonia or dopa-responsive dystonia
- •To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis (this voice box exam is not part of the study)
排除标准
- •Any evidence of a secondary cause for dystonia (other than myoclonus dystonia or dopa-responsive dystonia)
- •Less than 2 months since last botulinum toxin injection
- •Inability to provide informed consent
- •Significant medical or neurological conditions that preclude completing the neurological exam
- •Significant physical or other condition that would confound diagnosis or evaluation, other than dystonia or tremor
结局指标
主要结局
Observational
时间窗: 7 years
There is no primary outcome measure as this is an observational study.
次要结局
未报告次要终点
研究者
Hyder A. Jinnah, MD, PhD
Principal Investigator
Emory University