MRI in Patients With Kennedy Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Muscle fat fraction
研究概览
简要总结
Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.
The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.
Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Confirmed Kennedy disease
排除标准
- •All contraindications for undergoing an MRI scan
- •Healthy controls
- •Inclusion Criteria:
- •Fit age and gender criteria
- •Exclusion Criteria:
- •All contraindications for undergoing an MRI scan
结局指标
主要结局
Muscle fat fraction
时间窗: One MRI scan per subject (exam lasts approximately 60 min.)
The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
次要结局
- Muscle strength(One muscle strength test per subject (exam lasts approximately 60 min.))
- Minimal dataset for data collection in Kennedy disease(Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.))
研究者
Julia Dahlqvist, MD
MD
Rigshospitalet, Denmark