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Static Graviceptive Functions in Patients With Cervical Dystonia (CD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirsten Elwischger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01180270
First received: July 14, 2010
Last updated: January 28, 2012
Last verified: January 2012
History of Changes
  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:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Subjective visual vertical (SVV), measured in degree (°) [ Time Frame: screening ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    head deviation of patients group in relaxed posture, measured in degrees (°)

  • degree of head deviation (°) [ Time Frame: 3 weeks after screening ] [ Designated as safety issue: No ]
    head deviation of patients group in relaxed posture, measured in degrees (°)

  • degree of head deviation (°) [ Time Frame: 9 weeks after screening ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 14, 2010
Last Updated: January 28, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by 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
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013