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

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ClinicalTrials.gov Identifier: NCT02894359
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

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.


Condition or disease Intervention/treatment
Cervical Dystonia, Primary Device: cone beam imagery of cervical spine

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : October 27, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018


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



Primary Outcome Measures :
  1. comparison of bone marks positions (degrees) in patients ans control motions [ Time Frame: baseline ]
    positions measured in degrees with computerized imaging



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894359


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
France
Fondation Ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Sophie Sangla, MD       ssangla@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Study Chair: Jean-Pierre BLETON, PhD Fondation OPH A de Rothschild
Principal Investigator: Sophie SANGLA, MD Fondation OPH A de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02894359     History of Changes
Other Study ID Numbers: SSA_2016_19
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Cervical spine
Musculoskeletal imagery
computer modelling of cervical spine
ConeBeam.

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases