Adaptation ReactionNCT02980419
Effects of Prolonged Roll-tilt in Healthy Human Subjects
A study testing presentation of visual and vestibular stimuli in people with Adaptation Reaction, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adaptation Reaction
- What is being tested?
- presentation of visual and vestibular stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to 31 May 2020
- 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, 1 recruiting
- Recruiting
University Hospital Zurich, Dept. of Neurology
Zurich, Canton of Zurich, 8091
Alexander Tarnutzer, MD, +41442551111, alexander.tarnutzer@usz.ch
Alexander A Tarnutzer, MD
About this study
Official title: 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.
- Conditions
- Adaptation Reaction
- Being tested
- presentation of visual and vestibular stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presentation of visual and vestibular stimuliBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: presentation of visual and vestibular stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
Measured: 10 minutes (i.e. short-term adaptation)
changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus
This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
Measured: 10 minutes (i.e. short-term adaptation)
changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus
This is the same as in outcome 1, but an additional visual (optokinetic) stimulus is added
Measured: 10 minutes (i.e. short-term adaptation)
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 startJun 2016
- Primary completion1 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adaptation ReactionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980419
- Sponsor's protocol ID
- post_tilt_study
- Status last verified
- Dec 2019
- First submitted
- 16 Nov 2016
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02980419
- Acronym / sponsor ID
- post_tilt_study
- Conditions
- Adaptation Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- 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 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 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 | Behavioral: presentation of visual and vestibular stimuliIn 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. |
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 |
|---|---|---|
| presentation of visual and vestibular stimuliIn 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. | Behavioural | intervention arm |
Primary outcome
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.
3 secondary outcomes
changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus
Time frame: 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)
changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus
Time frame: 10 minutes (i.e. short-term adaptation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing presentation of visual and vestibular stimuli in people with Adaptation Reaction, 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominik Straumann, MD (+41442551111, dominik.straumann@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 7 Jan 2020.