Clinical trial NCT03946046: Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
Official title: Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Cervical Dystonia
Keywords: Cervical dystonia
Botulinum toxin
Ultrasound-guided injection
CDIP58
TWSTRS-2
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Botulinum toxin injections are the treatment of choice for cervical dystonia. Even if this treatment is successful for most of the patients, partials or completes failures still remained.

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.

Detailed description: Open label non-randomised controlled clinical trial comparing clinical localization techniques and ultrasonography to guide injections of Botulinum toxin A.

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.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* 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:

* Woman pregnant, woman of childbearing age not taking effective contraception or breastfeeding
* 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

Primary outcomes:
measure: Cervical Dystonia Impact Profile 58 (CDIP-58)
timeFrame: 1 month after inclusion
Secondary outcomes:
measure: Placement of the injecting needle
timeFrame: the day of the inclusion
measure: GCI-I (Clinical Global Impressions - Improvement) patient scale
timeFrame: 1 month after inclusion
measure: TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only
timeFrame: 1 month after inclusion
measure: TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale
timeFrame: 1 month after inclusion
measure: Rate of Adverse Events
timeFrame: 1 month after inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A
Study officials:
affiliation: Hôpital Roger Salengro, CHRU Lille
name: Alexandre KREISLER, MD, Ph
role: PRINCIPAL_INVESTIGATOR
References: