Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
2021년 6월 24일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
63
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seine-Saint-Denis
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Bobigny, Seine-Saint-Denis, 프랑스, 93009
- Avicenne Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
기간: Up to twelve months
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Comparison of the patients' age between PD and AP groups
기간: 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
기간: 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
기간: 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
기간: 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)
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Baseline
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Comparison of the patients' daily need in levodopa between PD and AP groups
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline
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Percentage of patients treated with apomorphine (%) in both groups
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Baseline
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Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia
기간: Baseline
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Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups
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Baseline
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Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia
기간: Baseline
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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)
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Baseline
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Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
기간: Baseline
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Duration of the disease (years since diagnosis of AP or PD) of patients
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Baseline
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Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia
기간: Baseline
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Percentage of female (%)
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Baseline
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Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
기간: Day 0
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Muscle affected by dystonia (described with International Anatomical Terminology)
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Day 0
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Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
기간: Day 0
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Duration of the dystonia (years since first report of the dystonia)
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Day 0
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Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bertrand Degos, MD,PhD, Hospital AVICENNE
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 9월 1일
기본 완료 (실제)
2021년 2월 11일
연구 완료 (실제)
2021년 2월 11일
연구 등록 날짜
최초 제출
2021년 6월 6일
QC 기준을 충족하는 최초 제출
2021년 6월 24일
처음 게시됨 (실제)
2021년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 24일
마지막으로 확인됨
2021년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CLEA-2021-167
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .