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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

Tracking Information
First Submitted Date July 14, 2010
First Posted Date August 12, 2010
Last Update Posted Date January 31, 2012
Study Start Date June 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2010)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 11, 2010)
  • 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 (°)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Static Graviceptive Functions in Patients With Cervical Dystonia (CD)
Official Title Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
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.
Detailed Description

Background:

The pathophysiological mechanism of cervical dystonia remains unclear. Affection of static graviceptive function has been shown in these patients by measuring the Subjective Visual Vertical (SVV). Healthy subjects, tested with voluntary head tilt, would tilt SVV in the opposite direction of the head. (Müller "E" effect), whereas patients with cervical dystonia set SVV close to true upright with a minimal deviation toward head-tilt. The mechanism of this change in otolith activity in patients with cervical dystonia is still unknown. When treated with botulinum toxin, head deviation will be reversed during a period of approximate 6-9 weeks, with a first peak of action after approximate 3 weeks.

Aim

The aim of this study is to investigate the effect of normalization of the head position under routine intramuscular botulinum toxin application in the cervical muscles (screening, 3 weeks and 9 weeks after injection) on static graviceptive function in patients with cervical dystonia.

Rationale

To our knowledge, the effect of botulinum toxin therapy on static otolith function in patients with cervical dystonia has never been evaluated. This study may provide new informations on the neural plasticity of the vestibular system and may contribute to the understanding of pathophysiological mechanisms of cervical dystonia. Accordingly, it may help developing new treatment strategies for this disease.

Primary hypothesis

There is a difference of at least 6 degrees in subjective visual vertical of patients with CD tested in habitual head position at study inclusion and 3 weeks after injection of Botulinum Toxin.

Study design

Subjective visual vertical will be tested in Patients with CD, who are pre-treated with botulinum toxin and show a good treatment response.

Patients SVV will be assessed before routine botulinum toxin injection (on day of injection), 3 and 9 weeks after injection. For control, SVV will be assessed in normal subjects.

SVV assessment

SVV will be performed by the patient and control while sitting upright in a dark room in different head positions, the head is fixed using a head holder.

In CD patients, SVV will be assessed in different head positions:

  1. the habitual head deviation (head deviation will be classified by Tsui score),
  2. head fixed in neutral head position (defined as 0° or no head rotation).
  3. ear deviated 15° and 30° to ipsilateral and contralateral side, respectively, starting at habitual head deviation

SVV in normal subject, with

A) head fixed in neutral position (defined as 0° or no head rotation),

B) ear deviated 30° to the left,

C) ear deviated 30° to the right,

D) ear deviated 15° to the left,

E) ear deviated 15° to the right, will be assessed.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Cervical Dystonia
Intervention Not Provided
Study Groups/Cohorts
  • Cervical dystonia

    patients suffering from cervical dystonia

    under routine botulinum toxin treatment

  • healthy volunteers
    control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 28, 2012)
45
Original Estimated Enrollment
 (submitted: August 11, 2010)
10
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01180270
Other Study ID Numbers SVV_CD1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kirsten Elwischger, Medical University of Vienna
Study Sponsor Kirsten Elwischger
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University of Vienna
Verification Date January 2012