Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
2021年6月24日 更新者：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.
調査の概要
状態
完了
研究の種類
観察的
入学 (実際)
63
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Seine-Saint-Denis
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Bobigny、Seine-Saint-Denis、フランス、93009
- Avicenne Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of the patients' age between PD and AP groups
時間枠：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
時間枠：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
時間枠：Baseline
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Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
|
Baseline
|
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Comparison of the patients' severity of the disease between PD and AP groups
時間枠：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
|
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Comparison of the patients' daily need in levodopa between PD and AP groups
時間枠：Baseline
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Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups
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Baseline
|
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Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups
時間枠：Baseline
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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
時間枠：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
時間枠：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
時間枠：Baseline
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Percentage of patients treated with deep brain stimulation (%) in both groups
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Baseline
|
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Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
|
Percentage of female (%)
|
Baseline
|
|
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 0
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Number of injection performed during injection appointment
|
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
時間枠：Day 0
|
Usage of ultrasound or electromyography to guide BoNT injection
|
Day 0
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Bertrand Degos, MD,PhD、Hospital AVICENNE
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月1日
一次修了 (実際)
2021年2月11日
研究の完了 (実際)
2021年2月11日
試験登録日
最初に提出
2021年6月6日
QC基準を満たした最初の提出物
2021年6月24日
最初の投稿 (実際)
2021年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月2日
QC基準を満たした最後の更新が送信されました
2021年6月24日
最終確認日
2021年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CLEA-2021-167
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個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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