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

Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Cervical Dystonia
• Intervention / Treatment: Procedure: Clinical targeting; Procedure: Ultrasonography targeting

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Clinical targeting; Clinical localization method (observation and palpation of target muscles)	Procedure: 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)
EXPERIMENTAL: Ultrasonography targeting; Ultrason-guided method	Procedure: Ultrasonography targeting; The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Dystonia Impact Profile 58 (CDIP-58)	Variation of the total score obtained with The Cervical Dystonia Impact Profile	1 month after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placement of the injecting needle	Assessment of the accurate placement of the injecting needle within the target muscle by ultrasonography in patients injected by the clinical targeting method (number and percent of discordances)	the day of the inclusion
GCI-I (Clinical Global Impressions - Improvement) patient scale	Variation of the GCI-I (Clinical Global Impressions - Improvement) patient scale : = Very much improved : nearly all better; good level of functioning; minimal symptoms; represents a very substantial change; = Much improved : notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain; = Minimally improved : slightly better with little or no clinically meaningful reduction of symptoms. Represents very little change in basic clinical status, level of care, or functional capacity; = No change : symptoms remain essentially unchanged; = Minimally worse : slightly worse but may not be clinically meaningful; may represent very little change in basic clinical status or functional capacity; = Much worse : clinically significant increase in symptoms and diminished functioning; = Very much worse : severe exacerbation of symptoms and loss of functioning	1 month after inclusion
TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only	Variation of the TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only Total score = 0 (no pain) to 40 (maximal pain)	1 month after inclusion
TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale	Variation of the TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale Total score = 0 (no psychiatric disorders) to 24 (important psychiatric disorders)	1 month after inclusion
Rate of Adverse Events	Adverse events related to the botulinum toxin injection (pain, swallowing disorders, hematoma, muscular weakness, dry mouth)	1 month after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Alexandre KREISLER, MD, Ph, Hôpital Roger Salengro, CHRU Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2019
• Primary Completion (ACTUAL): April 14, 2020
• Study Completion (ACTUAL): April 14, 2020

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Botulinum toxin; Ultrasound-guided injection; Cervical dystonia; CDIP58; TWSTRS-2
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis
• Other Study ID Numbers: 2017_68; 2018-A02045-50 (REGISTRY: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No