NCT03946046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 26, 2019

Last Update Submit

April 22, 2021

Conditions

Idiopathic Cervical Dystonia

Keywords

Cervical dystoniaBotulinum toxinUltrasound-guided injectionCDIP58TWSTRS-2

Outcome Measures

Primary Outcomes (1)

  • Cervical Dystonia Impact Profile 58 (CDIP-58)

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

    1 month after inclusion

Secondary Outcomes (5)

  • Placement of the injecting needle

    the day of the inclusion

  • GCI-I (Clinical Global Impressions - Improvement) patient scale

    1 month after inclusion

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

    1 month after inclusion

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

    1 month after inclusion

  • Rate of Adverse Events

    1 month after inclusion

Study Arms (2)

Clinical targeting

EXPERIMENTAL

Clinical localization method (observation and palpation of target muscles)

Procedure: Clinical targeting

Ultrasonography targeting

EXPERIMENTAL

Ultrason-guided method

Procedure: Ultrasonography targeting

Interventions

Clinical targetingPROCEDURE

The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles)

Clinical targeting
Ultrasonography targetingPROCEDURE

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

Ultrasonography targeting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lille, 59037, France

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre KREISLER, MD, Ph

    Hôpital Roger Salengro, CHRU Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 10, 2019

Study Start

March 27, 2019

Primary Completion

April 14, 2020

Study Completion

April 14, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

FR(1)