NCT02894359

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.

Trial Health

87
On Track

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 Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

September 5, 2016

Last Update Submit

January 23, 2019

Conditions

Cervical Dystonia, Primary

Keywords

Cervical spineMusculoskeletal imagerycomputer modelling of cervical spineConeBeam.

Outcome Measures

Primary Outcomes (1)

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

    positions measured in degrees with computerized imaging

    baseline

Study Arms (2)

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

Interventions

cone beam imagery of cervical spineDEVICE
CD patientscontrol subjects

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Cervical Dystonia, Primary

Study Officials

  • Jean-Pierre BLETON, PhD

    Fondation OPH A de Rothschild

    STUDY CHAIR

  • Sophie SANGLA, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

October 27, 2016

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

FR(1)