NCT02980419

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

3.9 years

First QC Date

November 16, 2016

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • adjustment errors of the subjective visual/haptic/postural vertical in upright position after prolonged whole-body roll-tilt positions.

    the accuracy and precision of visual vertical adjustments after prolonged roll tilt are quantified.

    10 minutes (i.e. short-term adaptation)

Secondary Outcomes (3)

  • changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus

    10 minutes (i.e. short-term adaptation)

  • changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus

    10 minutes (i.e. short-term adaptation)

  • changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus

    10 minutes (i.e. short-term adaptation)

Study Arms (1)

intervention arm

EXPERIMENTAL

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

Interventions

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.

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 Sites (1)

University Hospital Zurich, Dept. of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Central Study Contacts

Dominik Straumann, MD

CONTACT

Alexander A Tarnutzer, MD

CONTACT

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

November 16, 2016

First Posted

December 2, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 31, 2020

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations