Three-dimensional Analysis of Obliquus Capitis Inferior Muscle Function in the Rotatory Form of Cervical Dystonia (STOCI)

December 9, 2025 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 Mode CT Scanning :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

Status

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Terminated

Conditions

Conditions

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Study Type

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Observational

Enrollment (Actual)

Enrollment

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21

Contacts and Locations

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Study Contact

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Study Contact Backup

Study Locations

  • France
      • Paris, France, 75019
        • Hopital Fondation Adolphe de Rothschild

Participation Criteria

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Eligibility Criteria

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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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Pierre Bleton, Hopital Fondation Adolphe de Rothschild

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2024

Primary Completion (Actual)

Primary Completion

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July 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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