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

Primary Purpose

Idiopathic Cervical Dystonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical targeting
Ultrasonography targeting
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Cervical Dystonia focused on measuring Cervical dystonia, Botulinum toxin, Ultrasound-guided injection, CDIP58, TWSTRS-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical targeting

Ultrasonography targeting

Arm Description

Clinical localization method (observation and palpation of target muscles)

Ultrason-guided method

Outcomes

Primary Outcome Measures

Cervical Dystonia Impact Profile 58 (CDIP-58)
Variation of the total score obtained with The Cervical Dystonia Impact Profile

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2019
Last Updated
April 22, 2021
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03946046
Brief Title
Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
Acronym
RINOCERAUS
Official Title
Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Cervical Dystonia
Keywords
Cervical dystonia, Botulinum toxin, Ultrasound-guided injection, CDIP58, TWSTRS-2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical targeting
Arm Type
Experimental
Arm Description
Clinical localization method (observation and palpation of target muscles)
Arm Title
Ultrasonography targeting
Arm Type
Experimental
Arm Description
Ultrason-guided method
Intervention Type
Procedure
Intervention Name(s)
Clinical targeting
Intervention Description
The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles)
Intervention Type
Procedure
Intervention Name(s)
Ultrasonography targeting
Intervention Description
The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
Primary Outcome Measure Information:
Title
Cervical Dystonia Impact Profile 58 (CDIP-58)
Description
Variation of the total score obtained with The Cervical Dystonia Impact Profile
Time Frame
1 month after inclusion
Secondary Outcome Measure Information:
Title
Placement of the injecting needle
Description
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)
Time Frame
the day of the inclusion
Title
GCI-I (Clinical Global Impressions - Improvement) patient scale
Description
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
Time Frame
1 month after inclusion
Title
TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only
Description
Variation of the TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only Total score = 0 (no pain) to 40 (maximal pain)
Time Frame
1 month after inclusion
Title
TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale
Description
Variation of the TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale Total score = 0 (no psychiatric disorders) to 24 (important psychiatric disorders)
Time Frame
1 month after inclusion
Title
Rate of Adverse Events
Description
Adverse events related to the botulinum toxin injection (pain, swallowing disorders, hematoma, muscular weakness, dry mouth)
Time Frame
1 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre KREISLER, MD, Ph
Organizational Affiliation
Hôpital Roger Salengro, CHRU Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia

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