Study Stopped
This protocol was re-written and resubmitted under a different trial number again (NCT02980419)
Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation 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"). Here we evaluate different potential explanations for this bias using both vision-dependent and vision-independent paradigms of verticality perception.
Trial Health
Trial Health Score
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Started Jun 2016
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedJuly 2, 2018
June 1, 2018
1 month
April 26, 2016
June 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjustment errors and trial-to-trial variability as assessed by line adjustments (subjective visual vertical (SVV)), adjustments of a rod (subjective haptic vertical (SHV)) or self-adjustments (subjective postural vertical (SPV)) after prolonged roll
In all three paradigms (SVV, SHV and SPV) the percept of direction of gravity will be assessed. Parameters will be adjustment errors ("accuracy") and trial-to-trial variability ("precision") based on repetitive adjustments of a luminous line (SVV) or a rod (SHV) after returning to upright position after a period of 5min in static roll-tilt at 90° left-ear down or right-ear down. During the roll-tilt period subjects remain either in the dark or observe a rotating optokinetic (random dot) pattern. Individual mean values and standard deviation (SD) will be calculated for all conditions. Adjustments with the joystick (SPV) will start from 90° ear-down positions after 5min of static roll.
measurements will be obtained over periods of 5min in a single session and day
Secondary Outcomes (1)
Impact of a rotating optokinetic stimulus (velocity 60°/s) on adjustment errors as assessed by the SVV, the SHV or the SPV after 5min of static roll-tilt at +/- 90° roll.
measurements will be obtained over periods of 5min in a single session and day
Study Arms (1)
Single intervention arm
EXPERIMENTALThis is the only arm in this study, measuring verticality perception after prolonged roll-tilt over 5min.
Interventions
subjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt.
Eligibility Criteria
You may qualify if:
- ages 18-65 years
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Dominik Straumann, MD
University of Zurich, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 3, 2016
Study Start
June 1, 2016
Primary Completion
July 1, 2016
Study Completion
June 28, 2018
Last Updated
July 2, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share