Exploration of the Association Between White Matter Lesion Burden and Dalfampridine Response in Insidious-Onset Vascular Parkinsonism (DAL-VaP)
An Exploratory Cohort Study to Evaluate Whether White Matter Lesion Burden Correlates With Dalfampridine Response in Insidious-Onset Vascular Parkinsonism and Parkinson-Plus Syndromes
研究概览
地位
条件
详细说明
Insidious-onset vascular parkinsonism (VaP) is characterized by typical clinical manifestations including gait impairment, postural instability, poor levodopa responsiveness, and diffuse cerebral white matter lesions (WMLs). Dalfampridine is an agent indicated to manage gait dysfunction among patients diagnosed with multiple sclerosis. This study will collect standardized gait and functional scale assessments in participants with insidious-onset VaP and participants with Parkinson-plus syndromes (PPS).
Single-center observational cohort study performed at Tangdu Hospital, Fourth Military Medical University, Xi'an, China. Parkinsonism and poor levodopa response will be divided into two diagnostic subgroups (VaP, PPS). Each subgroup will receive one of two treatment regimens: dalfampridine 10 mg twice daily for 4 weeks plus conventional therapy, or conventional therapy alone.
Change in Timed Up and Go (TUG) test time,10-meter walking speed, Tinetti scale score, ADL scale score, FES-I score, FOG-Q score, and SF-36 summary scores recorded at baseline and Week 4 among participants with VaP.
Baseline white matter lesion volume will be documented as a baseline clinical characteristic of all enrolled participants.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Shaanxi
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Xi'an、Shaanxi、中国、710038
- Tangdu Hospital, Fourth Military Medical University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 18 years
- Clinical diagnosis of insidious-onset vascular parkinsonism or Parkinson-plus syndromes
- Gait, balance, or mobility impairment
- Poor levodopa response (<10% improvement in UPDRS-III after levodopa challenge)
- Ability to complete all study assessments
Exclusion Criteria:
- Seizure disorder or epilepsy
- Multiple sclerosis
- Repeated traumatic brain injury
- Encephalitis, brain tumor, or normal-pressure hydrocephalus
- Severe peripheral neuropathy
- Severe systemic illness or active infection
- Other neurological/psychiatric conditions interfering with assessments
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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VaP + Dalfampridine
Patients with insidious-onset vascular parkinsonism treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
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VaP + Conventional Therapy
Patients with insidious-onset vascular parkinsonism treated with conventional therapy alone for 4 weeks.
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PPS + Dalfampridine
Patients with Parkinson-plus syndromes treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
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PPS + Conventional Therapy
Patients with Parkinson-plus syndromes treated with conventional therapy alone for 4 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Timed Up and Go (TUG) Time From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4.
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Baseline to Week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in 10-Meter Walk Test Speed From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in speed during the 10-Meter Walk Test from baseline to Week 4.
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Baseline to Week 4
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Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in total score on the full Tinetti Balance and Gait Scale from baseline to Week 4. The scale ranges from 0 to 28; higher scores indicate superior balance and walking function.
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Baseline to Week 4
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Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in total score on the full Activities of Daily Living (ADL) Scale from baseline to Week 4. Scores range from 0 to 100; higher scores reflect better daily living performance.
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Baseline to Week 4
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Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in total score on the full Falls Efficacy Scale-International (FES-I) from baseline to Week 4. Scores range from 16 to 64; higher scores correspond to greater fear of falling.
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Baseline to Week 4
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Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in total score on the full Freezing of Gait Questionnaire (FOG-Q) from baseline to Week 4. Scores range from 0 to 24; higher scores mean more severe gait freezing symptoms.
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Baseline to Week 4
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Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4
大体时间：Baseline to Week 4
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Change in Physical Component Summary and Mental Component Summary scores on the full SF-36 Health Survey from baseline to Week 4. Each summary score ranges from 0 to 100; higher scores represent better physical or mental health status.
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Baseline to Week 4
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合作者和调查者
调查人员
- 首席研究员：Wei Zhang, MD, PhD、Tang-Du Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- K202307-10
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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