Gaze Holding in HumansNCT02185313
Gaze Holding in Cerebellar Patients
A study testing visual stimulus to follow in people with Gaze Holding in Humans and Rebound in Humans, 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 cerebellum a) controls gaze holding and compensates for impaired gaze stability and b) modulates vestibular information that is forward-ed from the labyrinth and brought to perception. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gaze Holding in Humans, Rebound in Humans
- What is being tested?
- visual stimulus to follow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to 30 Nov 2019
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 18-85
- informed consent
- for group 1: acute (i.e. symptom onset <14 days ago) cerebellar ischemia or hemorrhage as confirmed by clinical examination and brain imaging (CT or MRI)
- for group 2: chronic cerebellar degeneration as confirmed by clinical examination (presence of downbeat-nystagmus and / or gaze-evoked nystagmus and / or ataxia of gait and stance) in the absence of focal lesions (as previous cerebellar stroke, mass lesion or inflammation) on clinical routine cerebellar imaging
- absence of exclusion criteria
Who cannot join
- has MRI contraindications such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
- disturbed consciousness
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Verticality Perception and Gaze Holding in Healthy Human Subjects and Patients With Acute and Chronic Cerebellar Disorders
The long-term goal of this research is to advance the investigators knowledge of how the cerebellum a) controls gaze holding and compensates for impaired gaze stability and b) modulates vestibular information that is forward-ed from the labyrinth and brought to perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy human subjects, patients with chronic (degenerative) cerebellar disorders are inable to stabilize gaze in eccentric positions, resulting in eye drift towards primary (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can be observed in these patients. Unlike patients with de-generative cerebellar disorders, patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with acute deficits of gaze holding and verticality perception.
While a linear relationship between the amount of eye velocity drift and eccentricity of eye position has been proposed in healthy human subjects, others suggested non-linear behaviour. The strategy of this research is to characterize gaze holding and verticality perception in healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic degenerative cerebellar disorders and to relate eye movement findings with structural imaging of the cerebellum. The investigators will therefore analyze key cerebellar structures with regards to loss of volume and relate these imaging findings with the participants' ability to hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality perception in humans.
- Conditions
- Gaze Holding in Humans, Rebound in Humans
- Being tested
- visual stimulus to follow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual stimulus to followOther
| Study group | Role | What they receive |
|---|---|---|
| gaze holding | Experimental | Not described Receives: Other: visual stimulus to follow |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye velocity in relation to eye position
Measured: during the visual stimulus (5min)
Secondary outcomes (1)
symmetry of eye velocity for right vs. left gaze
Measured: during the visual stimulus (5min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startAug 2013
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaze Holding in HumansStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Straumann, Prof MD, Principal investigator, University Hospital Zurich, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185313
- Sponsor's protocol ID
- gaze_holding_cerebellar_zurich
- Status last verified
- Dec 2019
- First submitted
- 2 Jul 2014
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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
- Verticality Perception and Gaze Holding in Healthy Human Subjects and Patients With Acute and Chronic Cerebellar Disorders
- ClinicalTrials.gov ID
- NCT02185313
- Acronym / sponsor ID
- gaze_holding_cerebellar_zurich
- Conditions
- Gaze Holding in Humans, Rebound in Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Jul 2014 (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 cerebellum a) controls gaze holding and compensates for impaired gaze stability and b) modulates vestibular information that is forward-ed from the labyrinth and brought to perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy human subjects, patients with chronic (degenerative) cerebellar disorders are inable to stabilize gaze in eccentric positions, resulting in eye drift towards primary (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can be observed in these patients. Unlike patients with de-generative cerebellar disorders, patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with acute deficits of gaze holding and verticality perception.
While a linear relationship between the amount of eye velocity drift and eccentricity of eye position has been proposed in healthy human subjects, others suggested non-linear behaviour. The strategy of this research is to characterize gaze holding and verticality perception in healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic degenerative cerebellar disorders and to relate eye movement findings with structural imaging of the cerebellum. The investigators will therefore analyze key cerebellar structures with regards to loss of volume and relate these imaging findings with the participants' ability to hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality perception in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gaze holding | Experimental | Other: visual stimulus to follow |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ages 18-85
- informed consent
- for group 1: acute (i.e. symptom onset <14 days ago) cerebellar ischemia or hemorrhage as confirmed by clinical examination and brain imaging (CT or MRI)
- for group 2: chronic cerebellar degeneration as confirmed by clinical examination (presence of downbeat-nystagmus and / or gaze-evoked nystagmus and / or ataxia of gait and stance) in the absence of focal lesions (as previous cerebellar stroke, mass lesion or inflammation) on clinical routine cerebellar imaging
- absence of exclusion criteria
Key exclusion criteria (4 listed)
- has MRI contraindications such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
- disturbed consciousness
- other neurological or systemic disorder which can cause dementia or cognitive dysfunction
- Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test.
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 |
|---|---|---|
| visual stimulus to follow | Other | gaze holding |
Primary outcome
eye velocity in relation to eye position
Time frame: during the visual stimulus (5min)
1 secondary outcome
symmetry of eye velocity for right vs. left gaze
Time frame: during the visual stimulus (5min)
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 7 Jan 2020.
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.
Dominik Straumann, Prof MD principal investigator
University Hospital Zurich, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual stimulus to follow in people with Gaze Holding in Humans and Rebound in Humans, 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 5 inclusion and 4 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 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?
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?
eye velocity in relation to eye position (time frame: during the visual stimulus (5min)). 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.