- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980419
Effects of Prolonged Roll-tilt in Healthy Human Subjects
January 6, 2020 updated by: University of Zurich
Erticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dominik Straumann, MD
- Phone Number: +41442551111
- Email: dominik.straumann@usz.ch
Study Contact Backup
- Name: Alexander A Tarnutzer, MD
- Phone Number: +41442551111
- Email: alexander.tarnutzer@usz.ch
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Dept. of Neurology
-
Contact:
- Alexander Tarnutzer, MD
- Phone Number: +41442551111
- Email: alexander.tarnutzer@usz.ch
-
Sub-Investigator:
- Alexander A Tarnutzer, MD
-
Sub-Investigator:
- Andrea Wedtgrube
-
-
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes (i.e. short-term adaptation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 minutes (i.e. short-term adaptation)
|
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
|
10 minutes (i.e. short-term adaptation)
|
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
|
10 minutes (i.e. short-term adaptation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2016
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
November 16, 2016
First Submitted That Met QC Criteria
November 29, 2016
First Posted (Estimate)
December 2, 2016
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- post_tilt_study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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