Cervical DystoniaNCT01180270
Static Graviceptive Functions in Patients With Cervical Dystonia (CD)
An observational study of Cervical Dystonia, run by Kirsten Elwischger at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient botulinum toxin clinic of the department of neurology, medical university of Vienna healthy subjects, residents of vienna
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of neurology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
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.
Read the 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:
- the habitual head deviation (head deviation will be classified by Tsui score),
- head fixed in neutral head position (defined as 0° or no head rotation).
- ear deviated 15° and 30° to ipsilateral and contralateral side, respectively, starting at habitual head deviation
SVV in normal subject, with
- head fixed in neutral position (defined as 0° or no head rotation),
- ear deviated 30° to the left,
- ear deviated 30° to the right,
- ear deviated 15° to the left,
- ear deviated 15° to the right, will be assessed.
- Conditions
- Cervical Dystonia
- Keywords
- Cervical dystonia, torticollis spasmodicus, botulinum toxin, Subjective visual vertical (SVV), SVV, static graviceptive function
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical dystonia | patients suffering from cervical dystonia under routine botulinum toxin treatment | |
| healthy volunteers | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 9 weeks after screening
Secondary outcomes (3)
Degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Measured: screening
degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Measured: 3 weeks after screening
degree of head deviation (°)
head deviation of patients group in relaxed posture, measured in degrees (°)
Measured: 9 weeks after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Elwischger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Elwischger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180270
- Sponsor's protocol ID
- SVV_CD1
- Status last verified
- Jan 2012
- First submitted
- 14 Jul 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17383228Bove 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.
PubMed 15355873
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT01180270
- Acronym / sponsor ID
- SVV_CD1
- Conditions
- Cervical Dystonia
- Keywords
- Cervical dystonia, torticollis spasmodicus, botulinum toxin, Subjective visual vertical (SVV), SVV, static graviceptive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kirsten ElwischgerUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the habitual head deviation (head deviation will be classified by Tsui score),
- head fixed in neutral head position (defined as 0° or no head rotation).
- ear deviated 15° and 30° to ipsilateral and contralateral side, respectively, starting at habitual head deviation
SVV in normal subject, with
- head fixed in neutral position (defined as 0° or no head rotation),
- ear deviated 30° to the left,
- ear deviated 30° to the right,
- ear deviated 15° to the left,
- ear deviated 15° to the right, will be assessed.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical dystonia | – | –patients suffering from cervical dystonia under routine botulinum toxin treatment |
| healthy volunteers | – | –control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient botulinum toxin clinic of the department of neurology, medical university of Vienna healthy subjects, residents of vienna
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients and Control
- History of vestibular disorders
- Patients
- Torticollis with >15°rotation
- Secondary CD (structural MRI lesions, Mb. Wilson)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Degree of head deviation (°)
Time frame: screening
degree of head deviation (°)
Time frame: 3 weeks after screening
degree of head deviation (°)
Time frame: 9 weeks after screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
- Background: PubMed 17383228Vacherot 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.
- Background: PubMed 15355873Bove 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.
Related trials for Cervical Dystonia
Enrolling by invitationPhase 2
Accelerating TMS for Cervical Dystonia
Isolated Cervical Dystonia
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
Recruiting
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
Cervical Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia, run by Kirsten Elwischger at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective visual vertical (SVV), measured in degree (°) (time frame: screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.