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Exploration of the Association Between White Matter Lesion Burden and Dalfampridine Response in Insidious-Onset Vascular Parkinsonism (DAL-VaP)

28 juin 2026 mis à jour par: Tang-Du Hospital

An Exploratory Cohort Study to Evaluate Whether White Matter Lesion Burden Correlates With Dalfampridine Response in Insidious-Onset Vascular Parkinsonism and Parkinson-Plus Syndromes

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Parkinsonisme vasculaire

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Chine
- Shaanxi
  - Xi'an, Shaanxi, Chine, 710038
    - Tangdu Hospital, Fourth Military Medical University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with insidious-onset vascular parkinsonism or Parkinson-plus syndromes, with gait impairment and poor levodopa response.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
VaP + Dalfampridine Patients with insidious-onset vascular parkinsonism treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
VaP + Conventional Therapy Patients with insidious-onset vascular parkinsonism treated with conventional therapy alone for 4 weeks.
PPS + Dalfampridine Patients with Parkinson-plus syndromes treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
PPS + Conventional Therapy Patients with Parkinson-plus syndromes treated with conventional therapy alone for 4 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change in Timed Up and Go (TUG) Time From Baseline to Week 4 Délai: Baseline to Week 4	Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4.	Baseline to Week 4

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change in 10-Meter Walk Test Speed From Baseline to Week 4 Délai: Baseline to Week 4	Change in speed during the 10-Meter Walk Test from baseline to Week 4.	Baseline to Week 4
Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4 Délai: Baseline to Week 4	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.	Baseline to Week 4
Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4 Délai: Baseline to Week 4	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.	Baseline to Week 4
Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4 Délai: Baseline to Week 4	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.	Baseline to Week 4
Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4 Délai: Baseline to Week 4	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.	Baseline to Week 4
Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4 Délai: Baseline to Week 4	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.	Baseline to Week 4

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tang-Du Hospital

Les enquêteurs

Chercheur principal: Wei Zhang, MD, PhD, Tang-Du Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2023

Achèvement primaire (Réel)

31 décembre 2024

Achèvement de l'étude (Réel)

31 janvier 2025

Dates d'inscription aux études

Première soumission

8 juin 2026

Première soumission répondant aux critères de contrôle qualité

28 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)