Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948684
Enrollment
63
Registered
2021-07-02
Start date
2017-09-01
Completion date
2021-02-11
Last updated
2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Parkinsonism, Dystonia, Parkinson Disease

Keywords

Botulinum toxinum, Dystonia, Parkinson Disease, Atypical Parkinsonism

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Hospital Avicenne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patientsUp to twelve monthsEvaluation 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

Secondary

MeasureTime frameDescription
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patientsUp to twelve monthsEvaluation 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

Other

MeasureTime frameDescription
Comparison of the patients' duration of disease between PD and AP groupsBaselineDuration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups
Comparison of the patients' severity of the disease between PD and AP groupsBaselineSeverity 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)
Comparison of the patients' daily need in levodopa between PD and AP groupsBaselineLevodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups
Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groupsBaselinePercentage of patients treated with apomorphine (%) in PD and AP groups
Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groupsBaselinePercentage of patients treated with deep brain stimulation (%) in PD and AP groups
Comparison of the patients' age between patients presenting with dystonia and patients without reported dystoniaBaselineAge in years
Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystoniaBaselinePercentage of patients treated with deep brain stimulation (%) in both groups
Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystoniaBaselinePercentage of patients treated with apomorphine (%) in both groups
Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystoniaBaselineLevodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups
Comparison of the patients' age between PD and AP groupsBaselineAge in years of patients from PD and AP groups
Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystoniaBaselineDuration of the disease (years since diagnosis of AP or PD) of patients
Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystoniaBaselinePercentage of female (%)
Comparison of the dystonia's characteristics between PD and AP groups : muscle affectedDay 0Muscle affected by dystonia (described with International Anatomical Terminology)
Comparison of the dystonia's characteristics between PD and AP groups : duration of dystoniaDay 0Duration of the dystonia (years since first report of the dystonia)
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : doseDay 0Dose of BoNT used (in mL)
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNTDay 0Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injectionDay 0Site of injection (described with International Anatomical Terminology)
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injectionsDay 0Number of injection performed during injection appointment
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidanceDay 0Usage of ultrasound or electromyography to guide BoNT injection
Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystoniaBaselineSeverity 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)
Comparison of the sex-ratio between PD and AP groupsScreeningPercentage of female (%) in PD and AP groups

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026