NCT05327985

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

April 7, 2022

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in posture and main movement rotation of the cervical spine

    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)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Pierre Bleton

    Hopital Fondation Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

September 10, 2024

Primary Completion

July 8, 2025

Study Completion

July 8, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations