Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
NCT ID: NCT03946046
Last Updated: 2021-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2019-03-27
2020-04-14
Brief Summary
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Usually, botulinum toxin injections are realized by clinical localization techniques (observation and palpation of target muscles). The use of Ultrasonography to guide injections of Botulinum toxin has theoretical benefits (as an improved precision, an improved reproducibility, the targeting of deep-seated muscles, and a lower risk of adverse events) but its interest has never been demonstrated.
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Detailed Description
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The primary outcome is to compare both techniques of injection regarding to the health impact of cervical dystonia (CDIP-58) measured 1 month after injection.
The results of this clinical trial will help the clinician to decide which strategy of injection is the most effective in terms of benefit/risk ratio to treat the cervical dystonia.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Clinical targeting
Clinical localization method (observation and palpation of target muscles)
Clinical targeting
The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles)
Ultrasonography targeting
Ultrason-guided method
Ultrasonography targeting
The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
Interventions
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Clinical targeting
The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles)
Ultrasonography targeting
The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
Eligibility Criteria
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Inclusion Criteria
* Focal idiopathic cervical dystonia treated by injections of Botulinum toxin type A (onabotulinumtoxinA, Botox® ; abobotulinumtoxinA, Dysport® ; or incobotulinumtoxinA, Xeomin®).
* Patient who have previously received at least 3 cycles of botulinum toxin A injections in this specific indication
* Injections realized with clinical targeting exclusively or ultrasonography targeting exclusively
* Patient who is not opposed to its participation in this study
* Patient affiliated to the Sécurité Sociale
* Patient able to comply with study procedures and study duration
Exclusion Criteria
* Contraindication of botulinum toxin injections as :
* Hypersensivity to the botulinum toxin A or to an excipient of the commercialized treatment (onabotulinumtoxinA, Botox® ; abobotulinumtoxinA, Dysport® ; incobotulinumtoxinA, Xeomin®)
* Generalized muscular activity disorder (Myasthenia gravis, Lambert-Eaton syndrome)
* Infection or inflammation of the injection site
* Concomitant treatment that can interact with botulinum toxin A or modify the function of the neuromuscular synapse junction (anticholinergics, curare and other myorelaxing agents, Aminoglycosides, amino-4-quinolines)
* Documented resistance to the botulinum toxin A
* Inability to receive the information, inability to participate to the all study duration, refusal to sign the consent
* EMG-guided botulinum toxin injections
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Alexandre KREISLER, MD, Ph
Role: PRINCIPAL_INVESTIGATOR
Hôpital Roger Salengro, CHRU Lille
Locations
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Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A
Lille, , France
Countries
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Other Identifiers
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2018-A02045-50
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017_68
Identifier Type: -
Identifier Source: org_study_id
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