Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia (RINOCERAUS)

University Hospital, Lille

Status

Completed

Conditions

Idiopathic Cervical Dystonia

Treatments

Procedure: Clinical targeting

Procedure: Ultrasonography targeting

Study type

Interventional

Funder types

Other

Identifiers

NCT03946046

2018-A02045-50 (Registry Identifier)

2017_68

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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