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Effects of Prolonged Roll-tilt in Healthy Human Subjects

This study is currently recruiting participants.
Verified November 2016 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980419
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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 Intervention
Adaptation Reaction Behavioral: presentation of visual and vestibular stimuli

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Zurich:

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

Secondary Outcome Measures:
  • changes in adjustment errors of the subjective visual vertical whne providing an aditional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
  • changes in adjustment errors of the subjective haptic vertical whne providing an aditional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]
  • changes in adjustment errors of the subjective postural vertical whne providing an aditional optokinetic stimulus [ Time Frame: 10 minutes (i.e. short-term adaptation) ]

Estimated Enrollment: 20
Study Start Date: June 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02980419     History of Changes
Other Study ID Numbers: post_tilt_study
First Submitted: November 16, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No