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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710038
- Tangdu Hospital, Fourth Military Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Timed Up and Go (TUG) Time From Baseline to Week 4
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in 10-Meter Walk Test Speed From Baseline to Week 4
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Wei Zhang, MD, PhD, Tang-Du Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- K202307-10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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