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Verticality Perception - Multisensory Contribution

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ClinicalTrials.gov Identifier: NCT02212704
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions [ Time Frame: During the turntable measurement (90 minutes) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
relative contribution of head- and trunk-based sensory systems based on Bayesian modelling [ Time Frame: while on the turntable (1.5 hours) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Verticality Perception - Multisensory Contribution
Official Title  ICMJE Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects
Brief Summary The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Verticality Perception in Healthy Human Subjects
  • Individual Contribution of Different Sensory Systems
Intervention  ICMJE
  • Other: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)
  • Other: 3D-video-head impulse testing
    Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study
  • Other: Vestibular-evoked myogenic potentials (VEMPs)
    Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study
Study Arms  ICMJE Experimental: Vestibular stimulation
This is the experimental paradigm applied in all participants
Interventions:
  • Other: Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)
  • Other: 3D-video-head impulse testing
  • Other: Vestibular-evoked myogenic potentials (VEMPs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
20
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ages 18-60 years
  • informed consent
  • absence of exclusion criteria

Exclusion Criteria:

  • peripheral-vestibular deficit
  • disturbed consciousness
  • history of sensory deficits
  • visual field deficits
  • other neurological or systemic disorder which can cause dementia or cognitive dysfunction
  • intake of antidepressants, sedatives, or neuroleptics
  • pregnancy, unless excluded by a negative pregnancy test
  • known neck pain or status post neck trauma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212704
Other Study ID Numbers  ICMJE perception_head_roll_zurich
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominik Straumann, Prof, MD University Hospital Zurich, Dept. of Neurology
PRS Account University of Zurich
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP