Idiopathic Cervical DystoniaRINOCERAUSNCT03946046
Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
A study testing Clinical targeting and Ultrasonography targeting in people with Idiopathic Cervical Dystonia, run by University Hospital, Lille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Cervical Dystonia
- What is being tested?
- Clinical targeting and Ultrasonography targeting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2019to 14 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A
Lille, 59037
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Cervical Dystonia
- Being tested
- Clinical targeting, Ultrasonography targeting
- Keywords
- Cervical dystonia, Botulinum toxin, Ultrasound-guided injection, CDIP58, TWSTRS-2
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical targetingProcedure or surgery
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 targetingProcedure or surgery
The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
| Study group | Role | What they receive |
|---|---|---|
| Clinical targeting | Experimental | Clinical localization method (observation and palpation of target muscles) Receives: Procedure: Clinical targeting |
| Ultrasonography targeting | Experimental | Ultrason-guided method Receives: Procedure: Ultrasonography targeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Dystonia Impact Profile 58 (CDIP-58)
Variation of the total score obtained with The Cervical Dystonia Impact Profile
Measured: 1 month after inclusion
Secondary outcomes (5)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 1 month after inclusion
Rate of Adverse Events
Adverse events related to the botulinum toxin injection (pain, swallowing disorders, hematoma, muscular weakness, dry mouth)
Measured: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start27 Mar 2019
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre KREISLER, MD, Ph, Principal investigator, Hôpital Roger Salengro, CHRU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946046
- Sponsor's protocol ID
- 2017_68
- Other IDs
- 2018-A02045-50
- Acronym
- RINOCERAUS
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
- ClinicalTrials.gov ID
- NCT03946046
- Acronym / sponsor ID
- RINOCERAUS / 2017_68
- Conditions
- Idiopathic Cervical Dystonia
- Keywords
- Cervical dystonia, Botulinum toxin, Ultrasound-guided injection, CDIP58, TWSTRS-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical targeting | Experimental | Procedure: Clinical targetingClinical localization method (observation and palpation of target muscles) |
| Ultrasonography targeting | Experimental | Procedure: Ultrasonography targetingUltrason-guided method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Woman pregnant, woman of childbearing age not taking effective contraception or breastfeeding
- Contraindication of botulinum toxin injections as :
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical targetingThe intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles) | Procedure or surgery | Clinical targeting |
| Ultrasonography targetingThe intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method | Procedure or surgery | Ultrasonography targeting |
Primary outcome
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
5 secondary outcomes
Placement of the injecting needle
Time frame: the day of the inclusion
GCI-I (Clinical Global Impressions - Improvement) patient scale
Time frame: 1 month after inclusion
TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only
Time frame: 1 month after inclusion
TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale
Time frame: 1 month after inclusion
Rate of Adverse Events
Time frame: 1 month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
Related trials for Idiopathic Cervical Dystonia
Recruiting
UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
Idiopathic Cervical Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre KREISLER, MD, Ph principal investigator
Hôpital Roger Salengro, CHRU Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical targeting and Ultrasonography targeting in people with Idiopathic Cervical Dystonia, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Dystonia Impact Profile 58 (CDIP-58) (time frame: 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.