- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02760173
Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
June 28, 2018 updated by: University of Zurich
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single intervention arm
This is the only arm in this study, measuring verticality perception after prolonged roll-tilt over 5min.
|
subjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: measurements will be obtained over periods of 5min in a single session and day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: measurements will be obtained over periods of 5min in a single session and day
|
During the 5min period with static roll at +/- 90deg ear-down positions subjects will be presented a rotating optokinetic stimulus (random dot pattern, clockwise or counter-clockwise rotation) in some conditions.
Adjustment errors and trial-to-trial variability of conditions with the optokinetic stimulus will be compared to those without the optokinetic stimulus.
|
measurements will be obtained over periods of 5min in a single session and day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominik Straumann, MD, University of Zurich, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
April 26, 2016
First Submitted That Met QC Criteria
April 29, 2016
First Posted (Estimate)
May 3, 2016
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- vert_perc_posttilt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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