An observational study in Cervical Dystonia, sponsored by Kirsten Elwischger. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-31.
Sponsored by Kirsten Elwischger · Observational
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.
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:
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.
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 126 observational studies indexed under Dystonia.
Browse Dystonia studies →Kirsten Elwischger is the lead sponsor of 2 studies on the registry; none are open to participants now.
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outpatient botulinum toxin clinic of the department of neurology, medical university of Vienna healthy subjects, residents of vienna
Exclusion Criteria:
Patients and Control
Patients
patients suffering from cervical dystonia under routine botulinum toxin treatment
control group
Subjective visual vertical (SVV), measured in degree (°)
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.
Time frame: screening
SVV in degree (°)
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.
Time frame: 3 weeks after screeening
SVV in degree (°)
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.
Time frame: 9 weeks after screening
Degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Time frame: screening
degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Time frame: 3 weeks after screening
degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Time frame: 9 weeks after screening
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Kirsten Elwischger