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Completed

NCT Number: NCT02894359

Computer Modelling of the Cervical Spine Movements in Cervical Dystonia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cone beam imagery of cervical spine

Device

Primary outcomes

  1. comparison of bone marks positions (degrees) in patients ans control motions

    Time frame: baseline

    positions measured in degrees with computerized imaging

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: STICOB

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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