Computer Modelling of the Cervical Spine Movements in Cervical Dystonia

NCT ID: NCT02894359

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-27
• Study Completion Date: 2018-10-25

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.

Conditions

Cervical Dystonia, Primary

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CD patients

10 patients with a cervical dystonia

cone beam imagery of cervical spine

Intervention Type: DEVICE

control subjects

10 healthy patients

cone beam imagery of cervical spine

Intervention Type: DEVICE

Interventions

cone beam imagery of cervical spine

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre BLETON, PhD

Role: STUDY_CHAIR

Fondation OPH A de Rothschild

Sophie SANGLA, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

Fondation Ophtalmique Adolphe de Rothschild

Paris, , France

Countries

France

Other Identifiers

SSA_2016_19

Identifier Type: -

Identifier Source: org_study_id