NCT02760173

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

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

April 26, 2016

Last Update Submit

June 28, 2018

Conditions

Keywords

verticality perception

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

EXPERIMENTAL

This is the only arm in this study, measuring verticality perception after prolonged roll-tilt over 5min.

Other: perception of vertical after static roll-tilt over 5min

Interventions

subjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt.

Single intervention arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

  • Dominik Straumann, MD

    University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
0

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