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

28 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Vasculair parkinsonisme

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in Timed Up and Go (TUG) Time From Baseline to Week 4 Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in 10-Meter Walk Test Speed From Baseline to Week 4 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tang-Du Hospital

Onderzoekers

Hoofdonderzoeker: Wei Zhang, MD, PhD, Tang-Du Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2023

Primaire voltooiing (Werkelijk)

31 december 2024

Studie voltooiing (Werkelijk)

31 januari 2025

Studieregistratiedata

Eerst ingediend

8 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)