Computer Modelling of the Cervical Spine Movements in Cervical Dystonia (STICOB)

January 23, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. It is the most frequent form of adult focal dystonia. The distribution of dystonic muscles is unique for each patient, explaining the variety of patterns encountered.

The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin injections and/or specific retraining therapy programmes. Therefore, analyzing the characteristics of abnormal head movements and identifying the dystonic muscles are the key points of these treatments.

To a better understanding of the posture and movement disorders of head and neck, we wish to establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy subjects built from images obtained with the "Cone Beam " system. Then we will compare the cervical posture and movements for each of ten CD patients matched in age and genre to the computer model. Comparison with patients' images in the axial plane reconstructed by computer with the 3-D computer model will lead to the description of various patterns of CD. Analysis of the musculoskeletal disturbances in CD should be a help to improve the localization of Botulinum Neurotoxin injection sites as well as retraining programmes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

10 CD patients without Botulinum neurotoxin injection in the preceding 3 months and 10 control subjects, age and gender matched.

All subjetcts included in the study will undergo cervical spine imagery with the cone beam device (static and cervical rotation).

Description

Inclusion Criteria:

  • Tonic form of focal or segmental cervical dystonia (diagnostic confirmed by a neurologist specialized in movement disorders) for CD patients, or absence of CD for control subjects
  • absence of treatment by botulinum neurotoxin, or last injection > 3 months
  • age > 18 and < 71 years
  • informed consent
  • medical insurance coverage

Exclusion Criteria:

  • CD mobile (clonic) and/or head tremor
  • patient unable to sit without moving the head during the examination (x-ray pictures with cone beam)
  • Other neurological disease with effect on the posture and/or movement of the cervical region
  • Pain or traumatism of the cervical region requiring medical or surgical treatment in the preceding 6 months
  • Pregnant or breast feeding patient
  • Participation in another research with a potential impact on evaluation criteria
  • patient under judiciary protection

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CD patients
10 patients with a cervical dystonia
Device: cone beam imagery of cervical spine
control subjects
10 healthy patients
Device: cone beam imagery of cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of bone marks positions (degrees) in patients ans control motions
Time Frame: baseline
positions measured in degrees with computerized imaging
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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 (Actual)

October 27, 2016

Primary Completion (Actual)

October 25, 2018

Study Completion (Actual)

October 25, 2018

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSA_2016_19

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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