Clinical trial NCT04948684: Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Atypical Parkinsonism
Dystonia
Keywords: Botulinum toxinum
Dystonia
Parkinson Disease
Atypical Parkinsonism
Lead sponsor: Hospital Avicenne
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2021-07-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients
timeFrame: Up to twelve months
Secondary outcomes:
measure: Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients
timeFrame: Up to twelve months
Other outcomes:
measure: Comparison of the patients' age between PD and AP groups
timeFrame: Baseline
measure: Comparison of the sex-ratio between PD and AP groups
timeFrame: Screening
measure: Comparison of the patients' duration of disease between PD and AP groups
timeFrame: Baseline
measure: Comparison of the patients' severity of the disease between PD and AP groups
timeFrame: Baseline
measure: Comparison of the patients' daily need in levodopa between PD and AP groups
timeFrame: Baseline
measure: Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups
timeFrame: Baseline
measure: Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups
timeFrame: Baseline
measure: Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia
timeFrame: Baseline
measure: Comparison of the dystonia's characteristics between PD and AP groups : muscle affected
timeFrame: Day 0
measure: Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia
timeFrame: Day 0
measure: Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose
timeFrame: Day 0
measure: Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT
timeFrame: Day 0
measure: Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection
timeFrame: Day 0
measure: Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections
timeFrame: Day 0
measure: Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance
timeFrame: Day 0
Locations:
city: Bobigny
country: France
facility: Avicenne Hospital
state: Seine-Saint-Denis
Study officials:
affiliation: Hospital Avicenne
name: Bertrand Degos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.