4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia (RINOCERAUS)

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

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.


Condition or disease Intervention/treatment Phase
Idiopathic Cervical Dystonia Procedure: Clinical targeting Procedure: Ultrasonography targeting Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : April 14, 2020
Actual Study Completion Date : April 14, 2020
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 :

    1. = Very much improved : nearly all better; good level of functioning; minimal symptoms; represents a very substantial change
    2. = Much improved : notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain
    3. = 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
    4. = No change : symptoms remain essentially unchanged
    5. = Minimally worse : slightly worse but may not be clinically meaningful; may represent very little change in basic clinical status or functional capacity
    6. = Much worse : clinically significant increase in symptoms and diminished functioning
    7. = 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
France
Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Alexandre KREISLER, MD, Ph Hôpital Roger Salengro, CHRU Lille
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date April 23, 2021
Actual Study Start Date  ICMJE March 27, 2019
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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)
  • 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 :
    1. = Very much improved : nearly all better; good level of functioning; minimal symptoms; represents a very substantial change
    2. = Much improved : notably better with significant reduction of symptoms; increase in the level of functioning but some symptoms remain
    3. = 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
    4. = No change : symptoms remain essentially unchanged
    5. = Minimally worse : slightly worse but may not be clinically meaningful; may represent very little change in basic clinical status or functional capacity
    6. = Much worse : clinically significant increase in symptoms and diminished functioning
    7. = Very much worse : severe exacerbation of symptoms and loss of functioning
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
Official Title  ICMJE Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Idiopathic Cervical Dystonia
Intervention  ICMJE
  • 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)
  • Procedure: Ultrasonography targeting
    The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
Study Arms  ICMJE
  • Experimental: Clinical targeting
    Clinical localization method (observation and palpation of target muscles)
    Intervention: Procedure: Clinical targeting
  • Experimental: Ultrasonography targeting
    Ultrason-guided method
    Intervention: Procedure: Ultrasonography targeting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2021)
132
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
150
Actual Study Completion Date  ICMJE April 14, 2020
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946046
Other Study ID Numbers  ICMJE 2017_68
2018-A02045-50 ( Registry Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre KREISLER, MD, Ph Hôpital Roger Salengro, CHRU Lille
PRS Account University Hospital, Lille
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院