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Effects of Prolonged Roll-tilt in Healthy Human Subjects

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ClinicalTrials.gov Identifier: NCT02980419
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The long-term goal of this research is to advance the investigators knowledge of how the brain combines the information of multiple sensory systems coding for spatial oriention and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). This effect could either be related to adaptation to the roll-tilted position (shifting the "null" position) or it could be related to changes in torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the first case a post-tilt bias is predicted independently of the experimental paradigm used, the second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to evaluate these hypotheses, the investigators will assess perceived vertical using both vision-dependent and vision-independent paradigms.

Condition or disease Intervention/treatment Phase
Adaptation Reaction Behavioral: presentation of visual and vestibular stimuli Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Erticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
Study Start Date : June 2016
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: intervention arm
In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.
Behavioral: presentation of visual and vestibular stimuli
In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.




Primary Outcome Measures :
  1. adjustment errors of the subjective visual/haptic/postural vertical in upright position after prolonged whole-body roll-tilt positions. [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
    the accuracy and precision of visual vertical adjustments after prolonged roll tilt are quantified.


Secondary Outcome Measures :
  1. changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
    This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added

  2. changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
    This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added

  3. changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
    This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 18-65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980419


Contacts
Contact: Dominik Straumann, MD +41442551111 dominik.straumann@usz.ch
Contact: Alexander A Tarnutzer, MD +41442551111 alexander.tarnutzer@usz.ch

Locations
Switzerland
University Hospital Zurich, Dept. of Neurology Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Alexander Tarnutzer, MD    +41442551111    alexander.tarnutzer@usz.ch   
Sub-Investigator: Alexander A Tarnutzer, MD         
Sub-Investigator: Andrea Wedtgrube         
Sponsors and Collaborators
University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02980419     History of Changes
Other Study ID Numbers: post_tilt_study
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No