- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327985
Three-dimensional Analysis of Obliquus Capitis Inferior Muscle Function in the Rotatory Form of Cervical Dystonia by Means of the Cone Beam (STOCI)
October 25, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild
STOCI: Three-dimensional Analysis of Obliquus Capitis Inferior Muscle Function in the Rotatory Form of Cervical Dystonia by Means of the Cone Beam:Prospective Cohort Study
Cervical dystonia is the most common form of focal dystonia in adults (50-82%).
It manifests itself by a abnormal attitude of the head, intermittent or permanent, due to involuntary contraction of the cervical muscles which appears or is accentuated on the occasion of voluntary movement and maintenance posture.
The distribution of dystonic muscles is specific to each patient explaining the diversity of patterns encountered.
The therapeutic management of DC is essentially local and symptomatic.
It is based on the realization of injections of neuro botulinum toxin (BoNT) targeting target (dystonic) muscles responsible for involuntary movements or posture abnormal.
Identifying the muscles involved is a step prerequisite for therapeutic intervention.The obliquus capitis inferior (OCI) also known as Lower Oblique belongs to the group of suboccipital muscles.It is the only suboccipital muscle that does not attach to the skull.
Its unilateral contraction causes ipsilateral rotation of C1 therefore of the head.
The length of the transverse process of the atlas gives it considerable rotary efficiency.
It is described as the cephalic rotation starter muscle.
It would perform the 30 first degrees of rotation.
The rotation of the whole column cervical would then be continued by the synergistic action of the muscle contralateral sternocleidomatoid and Spl.
ipsilateral.
The level of joint complex C1-C2 the amplitude of rotation corresponds to approximately 50% of the total rotation of the cervical spine.
In order to better understand the part played by the OCI muscle in the disorganization of posture and cervical movements in the axial plane (plane of rotation) in the rotary DC, the investigators want biomechanically analyze its function in pathological situation.
The physiology of this muscle is richly documented in healthy subjects.
But does this knowledge apply in DC? Acquisition of imagery by the "Cone Beam" or CBCT system (Cone Beam Computed Tomography) before and 5 weeks after the injection of BoNT, will allow the analysis of the displacement of each vertebrate.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean Pierre BLETON, PhD
- Phone Number: 01 48 03 56 21
- Email: jpbleton@for.paris
Study Contact Backup
- Name: Amelie YAVCHITZ, DR
- Phone Number: 01 48 03 64 54
- Email: ayavchitz@for.paris
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients suffering from predominantly rotatory focal cervical dystonia will be identified directly by investigators at the Fondation A. de Rothschild Hospital during abnormal movement consultations or during specialized rehabilitation sessions.
Description
Inclusion Criteria:
- Patients between the ages of 18 and 70
- Presenting with a diagnosed focal CD with predominantly rotational by a neurologist specialized in abnormal movements
- Receiving botulinum toxin injection at OIC level as part of his treatment
- Express consent to participate in the study
- Member of or beneficiary of a social security scheme
Exclusion Criteria:
- Mobile DC (scrapie and/or myoclonic) that cannot be controlled the recording time by the CBCT system
- Having already benefited from an injection of BoNT as part of their DC in the last three months
- Inability to sit still
- Neurological condition other than DC (parkinsonian syndrome typical or atypical, others.)
- Severe neck pain
- Known or suspected trauma or pathology of the cervical spine, other than DC, having required treatment in the last 6 month
- Same old surgery of the cervical spine
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding women (a urine pregnancy test will be carried out in women under 50)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in posture and main movement rotation of the cervical spine
Time Frame: Before (day0) and after injection of BoNT (after 8 weeks max)
|
Movement of primary rotation of the cervical spine on CBCT imaging will be described using the symmetry index (SI), based on the difference angular (in degrees) of the active amplitude of right rotation and left
|
Before (day0) and after injection of BoNT (after 8 weeks max)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JBN_2022_1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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