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Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

24. juni 2021 opdateret af: Arnaud Lapostolle, Hospital Avicenne

Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome

Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP).

Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia.

The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP.

The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

63

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
    • Seine-Saint-Denis
      • Bobigny, Seine-Saint-Denis, Frankrig, 93009
        • Avicenne Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients that have been evaluated in the Neurology department of Avicenne Hospital (academic medical center) between september 1st 2017 and february 11th 2021.

Data will be retrospectively collected within the medical records of those patients.

Beskrivelse

Inclusion Criteria:

  • Diagnosed Parkinson's disease or Atypical Parkinsonism
  • Age > 18 years
  • Reported dystonia
  • At least 1 injection with Botulinum toxin realized

Exclusion Criteria:

  • Refusal to participate in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients with dystonia secondary to atypical Parkinsonism or Parkinson's disease
Patients with dystonia secondary to idiopathic Parkinson's disease or atypical parkinsonism and treated with BoNT
Patients with atypical Parkinsonism or Parkinson's disease and no dystonia
Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Tidsramme: Up to twelve months
Evaluation by the patient of the efficacy of the former injection on an improvement scale ranging from 0 to 100% (minimum value : 0, maximum value : 100, higher scores mean a better outcome) systematically made in routine care during follow up appointment
Up to twelve months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Tidsramme: Up to twelve months
Evaluation by the patient of the duration of the period during which symptoms were improved (in weeks) systematically made in routine care during follow up appointment
Up to twelve months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the patients' age between PD and AP groups
Tidsramme: Baseline
Age in years of patients from PD and AP groups
Baseline
Comparison of the sex-ratio between PD and AP groups
Tidsramme: Screening
Percentage of female (%) in PD and AP groups
Screening
Comparison of the patients' duration of disease between PD and AP groups
Tidsramme: Baseline
Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
Baseline
Comparison of the patients' severity of the disease between PD and AP groups
Tidsramme: Baseline
Severity of the disease in both PD and AP groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)
Baseline
Comparison of the patients' daily need in levodopa between PD and AP groups
Tidsramme: Baseline
Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups
Baseline
Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups
Tidsramme: Baseline
Percentage of patients treated with apomorphine (%) in PD and AP groups
Baseline
Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups
Tidsramme: Baseline
Percentage of patients treated with deep brain stimulation (%) in PD and AP groups
Baseline
Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Age in years
Baseline
Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Percentage of patients treated with deep brain stimulation (%) in both groups
Baseline
Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Percentage of patients treated with apomorphine (%) in both groups
Baseline
Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups
Baseline
Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Severity of the disease in both groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)
Baseline
Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Duration of the disease (years since diagnosis of AP or PD) of patients
Baseline
Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia
Tidsramme: Baseline
Percentage of female (%)
Baseline
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
Tidsramme: Day 0
Muscle affected by dystonia (described with International Anatomical Terminology)
Day 0
Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
Tidsramme: Day 0
Duration of the dystonia (years since first report of the dystonia)
Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
Tidsramme: Day 0
Dose of BoNT used (in mL)
Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
Tidsramme: Day 0
Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
Tidsramme: Day 0
Site of injection (described with International Anatomical Terminology)
Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
Tidsramme: Day 0
Number of injection performed during injection appointment
Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance
Tidsramme: Day 0
Usage of ultrasound or electromyography to guide BoNT injection
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Avicenne

Samarbejdspartnere

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Ledende efterforsker: Bertrand Degos, MD,PhD, Hospital AVICENNE

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2017

Primær færdiggørelse (Faktiske)

11. februar 2021

Studieafslutning (Faktiske)

11. februar 2021

Datoer for studieregistrering

Først indsendt

6. juni 2021

Først indsendt, der opfyldte QC-kriterier

24. juni 2021

Først opslået (Faktiske)

2. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLEA-2021-167

Plan for individuelle deltagerdata (IPD)

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