Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
24 juni 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
63
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, Frankrike, 93009
- Avicenne Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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
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Patients with atypical Parkinsonism or Parkinson's disease and no dystonia
Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
Tidsram: Up to twelve months
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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
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Up to twelve months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
Tidsram: 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
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Up to twelve months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comparison of the patients' age between PD and AP groups
Tidsram: Baseline
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Age in years of patients from PD and AP groups
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Baseline
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Comparison of the sex-ratio between PD and AP groups
Tidsram: Screening
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Percentage of female (%) in PD and AP groups
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Screening
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Comparison of the patients' duration of disease between PD and AP groups
Tidsram: Baseline
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Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
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Baseline
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Comparison of the patients' severity of the disease between PD and AP groups
Tidsram: Baseline
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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
|
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Comparison of the patients' daily need in levodopa between PD and AP groups
Tidsram: 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
Tidsram: Baseline
|
Percentage of patients treated with apomorphine (%) in PD and AP groups
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Baseline
|
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Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups
Tidsram: Baseline
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Percentage of patients treated with deep brain stimulation (%) in PD and AP groups
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Baseline
|
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Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia
Tidsram: Baseline
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Age in years
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Baseline
|
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Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia
Tidsram: Baseline
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
Percentage of female (%)
|
Baseline
|
|
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
Tidsram: Day 0
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Muscle affected by dystonia (described with International Anatomical Terminology)
|
Day 0
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Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
Tidsram: Day 0
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Duration of the dystonia (years since first report of the dystonia)
|
Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
Tidsram: Day 0
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Dose of BoNT used (in mL)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
Tidsram: Day 0
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Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
Tidsram: Day 0
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Site of injection (described with International Anatomical Terminology)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
Tidsram: Day 0
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Number of injection performed during injection appointment
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance
Tidsram: Day 0
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Usage of ultrasound or electromyography to guide BoNT injection
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Day 0
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bertrand Degos, MD,PhD, Hospital AVICENNE
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Dressler D. Botulinum toxin drugs: brief history and outlook. J Neural Transm (Vienna). 2016 Mar;123(3):277-9. doi: 10.1007/s00702-015-1478-1. Epub 2015 Nov 11.
- Jankovic J. Botulinum toxin: State of the art. Mov Disord. 2017 Aug;32(8):1131-1138. doi: 10.1002/mds.27072. Epub 2017 Jun 22.
- Tolosa E, Compta Y. Dystonia in Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII7-13. doi: 10.1007/s00415-006-7003-6.
- Marsili L, Bologna M, Kojovic M, Berardelli A, Espay AJ, Colosimo C. Dystonia in atypical parkinsonian disorders. Parkinsonism Relat Disord. 2019 Sep;66:25-33. doi: 10.1016/j.parkreldis.2019.07.030. Epub 2019 Jul 23.
- Mills R, Bahroo L, Pagan F. An update on the use of botulinum toxin therapy in Parkinson's disease. Curr Neurol Neurosci Rep. 2015 Jan;15(1):511. doi: 10.1007/s11910-014-0511-3.
- Pacchetti C, Albani G, Martignoni E, Godi L, Alfonsi E, Nappi G. "Off" painful dystonia in Parkinson's disease treated with botulinum toxin. Mov Disord. 1995 May;10(3):333-6. doi: 10.1002/mds.870100317.
- Giladi N, Meer J, Honigman S. The use of botulinum toxin to treat "striatal" toes. J Neurol Neurosurg Psychiatry. 1994 May;57(5):659. doi: 10.1136/jnnp.57.5.659. No abstract available.
- Rieu I, Degos B, Castelnovo G, Vial C, Durand E, Pereira B, Simonetta-Moreau M, Sangla S, Fluchere F, Guehl D, Burbaud P, Geny C, Gayraud D, Ory-Magne F, Bouhour F, Llinares E, Derost P, Marques A, Durif F. Incobotulinum toxin A in Parkinson's disease with foot dystonia: A double blind randomized trial. Parkinsonism Relat Disord. 2018 Jan;46:9-15. doi: 10.1016/j.parkreldis.2017.10.009. Epub 2017 Oct 19.
- Lapostolle A, Houot M, Mongin M, Degos B. Comparison of Botulinum neurotoxin efficiency in dystonia associated with Parkinson's disease and atypical parkinsonism: a retrospective study with a self-reported improvement scale. J Neurol. 2022 Nov;269(11):6021-6028. doi: 10.1007/s00415-022-11280-y. Epub 2022 Jul 19.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2017
Primärt slutförande (Faktisk)
11 februari 2021
Avslutad studie (Faktisk)
11 februari 2021
Studieregistreringsdatum
Först inskickad
6 juni 2021
Först inskickad som uppfyllde QC-kriterierna
24 juni 2021
Första postat (Faktisk)
2 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2021
Senast verifierad
1 juni 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CLEA-2021-167
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