Analysis of Three-dimensional Movements of the Head in Cervical Dystonia (STAC1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02069548
First received: February 18, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.


Condition
Cervical Dystonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects

Resource links provided by NLM:


Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • Range of motion of the voluntary mobility of the cervical spine in the three spatial planes [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects


Secondary Outcome Measures:
  • movements disorders in cervical dystonia [ Time Frame: baseline ] [ Designated as safety issue: No ]
    correlations between the movements disorders (range of motion, angular velocity, direction deviation) and the clinical characteristics of cervical dystonia, among patients with cervical dystonia

  • head posture [ Time Frame: baseline ] [ Designated as safety issue: No ]
    influence of vision on the head posture

  • range of motion [ Time Frame: baseline ] [ Designated as safety issue: No ]
    influence of vision on the range of motion


Other Outcome Measures:
  • score on the Toronto Western Spasmodic torticolis rating scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
    clinical characteristics of cervical dystonia


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cervical dystonia
matched controlled subjects
matched in age (+/- 5 years) and gender

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris)

Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)

Criteria

Inclusion Criteria:

  • Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders

Exclusion Criteria:

  • Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
  • Neuroleptic treatment in course
  • Pregnancy
  • breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069548

Contacts
Contact: Laurence Salomon, MD, PhD +33148036431 lsalomon@fo-rothschild.fr

Locations
France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile de France, France, 75019
Contact: Laurence Salomon       lsalomon@fo-rothschild.fr   
Principal Investigator: Sophie SANGLA, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Sangla Sophie, MD Fondation Ophtalmologique Adolphe de Rothschild
  More Information

No publications provided

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02069548     History of Changes
Other Study ID Numbers: 2013-A01400-45
Study First Received: February 18, 2014
Last Updated: March 4, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on August 01, 2014