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Static Graviceptive Functions in Patients With Cervical Dystonia (CD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180270
First Posted: August 12, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kirsten Elwischger, Medical University of Vienna
  Purpose
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
Cervical Dystonia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Kirsten Elwischger, Medical University of Vienna:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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:
  • Degree of head deviation (°) [ Time Frame: screening ]
    head deviation of patients group in relaxed posture, measured in degrees (°)

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

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


Enrollment: 45
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cervical dystonia

patients suffering from cervical dystonia

under routine botulinum toxin treatment

healthy volunteers
control group

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
Austria
Department of neurology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Kirsten Elwischger
  More Information

Publications:
Responsible Party: Kirsten Elwischger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01180270     History of Changes
Other Study ID Numbers: SVV_CD1
First Submitted: July 14, 2010
First Posted: August 12, 2010
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:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs


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