HealthyNCT02980432
Verticality Perception Assessed by the Haptic Vertical
A study testing changes in whole-body roll position and visual/haptic stimuli presented in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators previously shown that a rotating optokinetic stimulus results in shifts of the subjective visual vertical in healthy human subjects. However, the origin of these shifts is still poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- changes in whole-body roll position and visual/haptic stimuli presented
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-65 years
- informed consent
- absence of exclusion criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept. of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Verticality Perception - Modulatory Effect of a Rotating Optokinetic Stimulus on the Haptic Vertical in Healthy Human Subjects
The investigators previously shown that a rotating optokinetic stimulus results in shifts of the subjective visual vertical in healthy human subjects. However, the origin of these shifts is still poorly understood. Both torsional displacement of the eyes and a shift in the internal estimate of direction of gravity have been proposed as potential explanations. Here the investigators use a vision-independent setup to differentiate between these two hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if torsion triggers the shift.
- Conditions
- Healthy
- Being tested
- changes in whole-body roll position and visual/haptic stimuli presented
- Keywords
- vestibular, spatial orientation, vision, optokinetic
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changes in whole-body roll position and visual/haptic stimuli presentedOther
In different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | all participants will be assigned to the same arm. Interventions applied include presenting a visual line or a rod with or without a moving (rotating) background while being in different whole-body roll positions. Participants will be asked to adjust the line or the rod along perceived direction of gravity. Receives: Other: changes in whole-body roll position and visual/haptic stimuli presented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
This outcome parameter focuses on the adjustment errors of the subjective haptic vertical while presenting a visual bias (i.e. an optokinetic rotatory stimulus).
Measured: 60 minutes
Trial-to-trial variability of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
This outcome parameter focuses on the trial-to-trial variability of rod alignments along perceived direction of gravity when presenting a visual bias cue (i.e. an optokinetic rotatory stimulus).
Measured: 60 minutes
Secondary outcomes (2)
Comparison of adjustment errors between the subjective haptic vertical and the subjective visual vertical
Measured: 60 minutes
Comparison of adjustment errors of perceived vertical using the subjective haptic vertical with and without presenting an optokinetic stimulus
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion1 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980432
- Sponsor's protocol ID
- shv_okn_study
- Status last verified
- Jun 2018
- First submitted
- 16 Nov 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verticality Perception - Modulatory Effect of a Rotating Optokinetic Stimulus on the Haptic Vertical in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02980432
- Acronym / sponsor ID
- shv_okn_study
- Conditions
- Healthy
- Keywords
- vestibular, spatial orientation, vision, optokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators previously shown that a rotating optokinetic stimulus results in shifts of the subjective visual vertical in healthy human subjects. However, the origin of these shifts is still poorly understood. Both torsional displacement of the eyes and a shift in the internal estimate of direction of gravity have been proposed as potential explanations. Here the investigators use a vision-independent setup to differentiate between these two hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if torsion triggers the shift.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: changes in whole-body roll position and visual/haptic stimuli presentedall participants will be assigned to the same arm. Interventions applied include presenting a visual line or a rod with or without a moving (rotating) background while being in different whole-body roll positions. Participants will be asked to adjust the line or the rod along perceived direction of gravity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 18-65 years
- informed consent
- absence of exclusion criteria
Key exclusion criteria (8 listed)
- peripheral-vestibular deficit
- disturbed consciousness
- history of sensory deficits
- visual field deficits
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| changes in whole-body roll position and visual/haptic stimuli presentedIn different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity. | Other | intervention arm |
Primary outcome
Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
Time frame: 60 minutes
This outcome parameter focuses on the adjustment errors of the subjective haptic vertical while presenting a visual bias (i.e. an optokinetic rotatory stimulus).
Trial-to-trial variability of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented.
Time frame: 60 minutes
This outcome parameter focuses on the trial-to-trial variability of rod alignments along perceived direction of gravity when presenting a visual bias cue (i.e. an optokinetic rotatory stimulus).
2 secondary outcomes
Comparison of adjustment errors between the subjective haptic vertical and the subjective visual vertical
Time frame: 60 minutes
Comparison of adjustment errors of perceived vertical using the subjective haptic vertical with and without presenting an optokinetic stimulus
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changes in whole-body roll position and visual/haptic stimuli presented in people with Healthy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjustment errors of aligning a rod along perceived direction of gravity while an optokinetic stimulus is presented. (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.