NCT01180270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.6 years

First QC Date

July 14, 2010

Last Update Submit

January 28, 2012

Conditions

Cervical Dystonia

Keywords

Cervical dystoniatorticollis spasmodicusbotulinum toxinSubjective visual vertical (SVV)SVVstatic graviceptive function

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    9 weeks after screening

Secondary Outcomes (3)

  • Degree of head deviation (°)

    screening

  • degree of head deviation (°)

    3 weeks after screening

  • degree of head deviation (°)

    9 weeks after screening

Study Arms (2)

Cervical dystonia

patients suffering from cervical dystonia under routine botulinum toxin treatment

healthy volunteers

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient botulinum toxin clinic of the department of neurology, medical university of Vienna healthy subjects, residents of vienna

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (2)

  • 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.

    PMID: 17383228BACKGROUND

  • 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.

    PMID: 15355873BACKGROUND

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 14, 2010

First Posted

August 12, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

AU(1)