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Completed

NCT Number: NCT03946046

Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia

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.

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Key information

Conditions

Idiopathic Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical targeting

Procedure

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

Procedure

The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method

Primary outcomes

  1. Cervical Dystonia Impact Profile 58 (CDIP-58)

    Time frame: 1 month after inclusion

    Variation of the total score obtained with The Cervical Dystonia Impact Profile

Secondary outcomes

  1. Placement of the injecting needle

    Time frame: the day of the inclusion

    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)

  2. GCI-I (Clinical Global Impressions - Improvement) patient scale

    Time frame: 1 month after inclusion

    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

  3. TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only

    Time frame: 1 month after inclusion

    Variation of the TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only

    Total score = 0 (no pain) to 40 (maximal pain)

  4. TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale

    Time frame: 1 month after inclusion

    Variation of the TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale

    Total score = 0 (no psychiatric disorders) to 24 (important psychiatric disorders)

  5. Rate of Adverse Events

    Time frame: 1 month after inclusion

    Adverse events related to the botulinum toxin injection (pain, swallowing disorders, hematoma, muscular weakness, dry mouth)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: RINOCERAUS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 10, 2019
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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