An Exploratory Cohort Study to Evaluate Whether White Matter Lesion Burden Correlates With Dalfampridine Response in Insidious-Onset Vascular Parkinsonism and Parkinson-Plus Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Timed Up and Go (TUG) Time From Baseline to Week 4
研究概览
简要总结
This single-center observational cohort study will be conducted at Tangdu Hospital, Fourth Military Medical University. Patients presenting parkinsonism and poor levodopa response will be enrolled, including insidious-onset vascular parkinsonism (VaP) and Parkinson-plus syndromes (PPS). Within each diagnostic subgroup, participants will receive either dalfampridine 10 mg twice daily for 4 weeks combined with conventional therapy, or conventional therapy alone. Change in Timed Up and Go (TUG) time, gait speed, balance, daily function, and quality of life metrics assessed from baseline to Week 4.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Timed Up and Go (TUG) Time From Baseline to Week 4
时间窗: Baseline to Week 4
Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4.
次要结局
- Change in 10-Meter Walk Test Speed From Baseline to Week 4(Baseline to Week 4)
- Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4(Baseline to Week 4)
- Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4(Baseline to Week 4)
- Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4(Baseline to Week 4)
- Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4(Baseline to Week 4)
- Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4(Baseline to Week 4)