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Static Graviceptive Functions in Patients With Cervical Dystonia (CD)

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ClinicalTrials.gov Identifier: NCT01180270
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Kirsten Elwischger, Medical University of Vienna

Study Description
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Brief Summary:
The purpose of this experimental pilot study is to test the effect of normalization of the head position on the sense of balance at patients with cervical dystonia under routine botulinum toxin treatment.

Condition or disease
Cervical Dystonia

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Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Prospective
Official Title: Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
Study Start Date : June 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Groups and Cohorts
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Group/Cohort
Cervical dystonia

patients suffering from cervical dystonia

under routine botulinum toxin treatment
healthy volunteers
control group


Outcome Measures
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Primary Outcome Measures :
  1. Subjective visual vertical (SVV), measured in degree (°) [ Time Frame: screening ]
    Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck. For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint. In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device. Patients adjust bar for parallel alignment with the perceived gravitational vertical. The operator tilts the bar in a random order 18° from the physical vertical.

  2. SVV in degree (°) [ Time Frame: 3 weeks after screeening ]
    Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck. For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint. In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device. Patients adjust bar for parallel alignment with the perceived gravitational vertical. The operator tilts the bar in a random order 18° from the physical vertical.

  3. SVV in degree (°) [ Time Frame: 9 weeks after screening ]
    Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck. For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint. In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device. Patients adjust bar for parallel alignment with the perceived gravitational vertical. The operator tilts the bar in a random order 18° from the physical vertical.


Secondary Outcome Measures :
  1. Degree of head deviation (°) [ Time Frame: screening ]
    head deviation of patients group in relaxed posture, measured in degrees (°)

  2. degree of head deviation (°) [ Time Frame: 3 weeks after screening ]
    head deviation of patients group in relaxed posture, measured in degrees (°)

  3. degree of head deviation (°) [ Time Frame: 9 weeks after screening ]
    head deviation of patients group in relaxed posture, measured in degrees (°)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
outpatient botulinum toxin clinic of the department of neurology, medical university of Vienna healthy subjects, residents of vienna
Criteria

Inclusion Criteria:

  • Idiopathic CD and willing to participate on the study,
  • Isolated laterocollis or laterocollis and torticollis with maximum of 15°rotation
  • Aged 18-80 years,
  • Under routine treatment with botulinum toxin

Exclusion Criteria:

Patients and Control

  • History of vestibular disorders

Patients

  • Torticollis with >15°rotation
  • Secondary CD (structural MRI lesions, Mb. Wilson)
  • Contraindication for intramuscular botulinum toxin therapy: bleeding disorder or anticoagulation therapy
Contacts and Locations
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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): NCT01180270


Locations
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Austria
Department of neurology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Kirsten Elwischger
More Information
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Publications:

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Responsible Party: Kirsten Elwischger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01180270    
Other Study ID Numbers: SVV_CD1
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by Kirsten Elwischger, Medical University of Vienna:
Cervical dystonia
torticollis spasmodicus
botulinum toxin
 Subjective visual vertical (SVV)
SVV
static graviceptive function
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases