Static Graviceptive Functions in Patients With Cervical Dystonia (CD)
NCT ID: NCT01180270
Last Updated: 2012-01-31
Study Results
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Basic Information
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COMPLETED
45 participants
OBSERVATIONAL
2010-06-30
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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Cervical dystonia
patients suffering from cervical dystonia
under routine botulinum toxin treatment
No interventions assigned to this group
healthy volunteers
control group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Isolated laterocollis or laterocollis and torticollis with maximum of 15°rotation
* Aged 18-80 years,
* Under routine treatment with botulinum toxin
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Kirsten Elwischger
OTHER
Responsible Party
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Kirsten Elwischger
MD
Locations
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Department of neurology, Medical University of Vienna
Vienna, Vienna, Austria
Countries
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References
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Vacherot F, Vaugoyeau M, Mallau S, Soulayrol S, Assaiante C, Azulay JP. Postural control and sensory integration in cervical dystonia. Clin Neurophysiol. 2007 May;118(5):1019-27. doi: 10.1016/j.clinph.2007.01.013. Epub 2007 Mar 23.
Bove M, Brichetto G, Abbruzzese G, Marchese R, Schieppati M. Neck proprioception and spatial orientation in cervical dystonia. Brain. 2004 Dec;127(Pt 12):2764-78. doi: 10.1093/brain/awh291. Epub 2004 Sep 8.
Other Identifiers
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SVV_CD1
Identifier Type: -
Identifier Source: org_study_id