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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Vaskulær Parkinsonisme

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in Timed Up and Go (TUG) Time From Baseline to Week 4 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in 10-Meter Walk Test Speed From Baseline to Week 4 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Tang-Du Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2023

Primær fullføring (Faktiske)

31. desember 2024

Studiet fullført (Faktiske)

31. januar 2025

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

28. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)