Reflex, AbnormalCS-TRIGGERNCT04268615
Covert Saccade Triggers in Bilateral Vestibular Hypofunction
A study testing Covert Saccades and Virtual Reality, Actives versus passives Head Impulses and Visually guided saccades in people with Reflex, Abnormal and Bilateral Vestibulopathy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflex, Abnormal, Bilateral Vestibulopathy, Healthy Volunteers
- What is being tested?
- Covert Saccades and Virtual Reality, Actives versus passives Head Impulses and Visually guided saccades
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2020to 21 Mar 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all :
- Age from 18 to 90
- Understanding of the experimental instructions
- Informed Consent
- For Patients :
- Bilateral vestibular hypofunction with regards to the criteria of the of the Barany Society A. Chronic vestibular syndrome with at least three of the following symptoms
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- Postural imbalance
- Unsteadiness of gait
- Movement-induced blurred vision or oscillopsia during walking or quick head/body movements
- Worsening of postural imbalance or unsteadiness of gait in darkness and/or on uneven ground B. No symptoms while sitting or lying down under static conditions C. Bilaterally reduced or absent angular VOR function documented by
- bilaterally pathological horizontal angular VOR gain < 0.6, measured by the video-HIT5or scleral-coil technique and/or
- reduced caloric response (sum of bithermal max. peak SPV on each side < 6°/sec7)and/or
- reduced horizontal angular VOR gain < 0.1 upon sinusoidal stimulation on a rotatorychair (0.1 Hz, Vmax = 50°/sec).
- Not better accounted for by another disease
- For Healthy control No ENT or neurological disorders
Who cannot join
- Corrected Visual Acuity lower than 5/10
- Other conditions leading to oscillopsia or ataxia
- Oculomotor palsy, ocular instability in primary position
- Treatment that may affect ocular motility (psychotropes)
- Cervical rachis pathology with instability
- Cochlear Implants
Show all 10Show fewer
- Non-stabilized medical disease
- Pregnant women
- Patients under tutelage
- Patient without social security
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.
- Being tested
- Covert Saccades and Virtual Reality, Actives versus passives Head Impulses, Visually guided saccades
- Keywords
- Saccadic Eye Movements, Bilateral Vestibulopathy, Bilateral Vestibular Hypofunction
- Medical subject headings
- Reflex, Abnormal, Bilateral Vestibulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covert Saccades and Virtual RealityOther
During this intervention, patients will undergo head impulse testing while wearing virtual reality Headsets. During the head impulse tests the visual information will be modified in order to create a conflict between head rotation and rotation of the visual scene. Recording of head and eye movement will be done during these head impulses in order to verify if visual information modifies compensatory eye movements during head impulses.
Actives versus passives Head ImpulsesOther
Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.
Visually guided saccadesOther
Patients as well as healthy control subjects will undergo testing of visually guided saccades in different conditions (step, gap, overlap) in order to compare latencies of covert saccades between both groups.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients suffering from chronic bilateral vestibular hypofunction Receives: Other: Covert Saccades and Virtual Reality; Other: Actives versus passives Head Impulses; Other: Visually guided saccades |
| healthy subject group | Active comparator | Not described Receives: Other: Covert Saccades and Virtual Reality; Other: Actives versus passives Head Impulses; Other: Visually guided saccades |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency of covert-saccades
Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade
Measured: Day 1
Secondary outcomes (4)
Frequency of covert-saccades
Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.
Measured: Day 1
Velocity of covert-saccades
Velocity of covert saccades correspond to the maximal velocity of the first covert-saccade
Measured: day 1
Amplitude of covert-saccades
Amplitude of covert saccades correspond to amplitude of the first covert-saccade
Measured: Day 1
Latency of visually-guided saccades
Latency of visually guided saccades correspond to the time between the appearance of target and the initiation of the first saccade
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start15 Dec 2020
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reflex, AbnormalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline FROMENT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268615
- Sponsor's protocol ID
- 69HCL19_0998
- Other IDs
- 2020-A00184-35
- Acronym
- CS-TRIGGER
- Status last verified
- Jul 2022
- First submitted
- 11 Feb 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lagadec V, Pelisson D, Koun E, Robert C, Froment Tilikete C, Hermann R. Oculomotor compensatory strategies in bilateral vestibulopathy: Predictive and active conditions of head movements. J Vestib Res. 2025 Nov;35(6):290-299. doi: 10.1177/09574271251355180. Epub 2025 Jun 21.
PubMed 40543046Hermann R, Ramat S, Colnaghi S, Lagadec V, Desoche C, Pelisson D, Froment Tilikete C. Catch-Up Saccades in Vestibulo-Ocular Reflex Deficit: Contribution of Visual Information? Ear Hear. 2025 May-Jun 01;46(3):719-728. doi: 10.1097/AUD.0000000000001616. Epub 2024 Dec 18.
PubMed 39690450Desoche C, Verdelet G, Salemme R, Farne A, Pelisson D, Froment C, Hermann R. Virtual reality set-up for studying vestibular function during head impulse test. Front Neurol. 2023 Mar 29;14:1151515. doi: 10.3389/fneur.2023.1151515. eCollection 2023.
PubMed 37064179
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covert Saccade Triggers in Bilateral Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT04268615
- Acronym / sponsor ID
- CS-TRIGGER / 69HCL19_0998
- Keywords
- Saccadic Eye Movements, Bilateral Vestibulopathy, Bilateral Vestibular Hypofunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Covert Saccades and Virtual Reality, Other: Actives versus passives Head Impulses, Other: Visually guided saccadesPatients suffering from chronic bilateral vestibular hypofunction |
| healthy subject group | Active comparator | Other: Covert Saccades and Virtual Reality, Other: Actives versus passives Head Impulses, Other: Visually guided saccades |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For all :
- For Patients :
- Bilateral vestibular hypofunction with regards to the criteria of the of the Barany Society A. Chronic vestibular syndrome with at least three of the following symptoms
- Postural imbalance
- Unsteadiness of gait
Key exclusion criteria (10 listed)
- Corrected Visual Acuity lower than 5/10
- Other conditions leading to oscillopsia or ataxia
- Oculomotor palsy, ocular instability in primary position
- Treatment that may affect ocular motility (psychotropes)
- Cervical rachis pathology with instability
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 |
|---|---|---|
| Covert Saccades and Virtual RealityDuring this intervention, patients will undergo head impulse testing while wearing virtual reality Headsets. During the head impulse tests the visual information will be modified in order to create a conflict between head rotation and rotation of the visual scene. Recording of head and eye movement will be done during these head impulses in order to verify if visual information modifies compensatory eye movements during head impulses. | Other | Patients, healthy subject group |
| Actives versus passives Head ImpulsesPatients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions. | Other | Patients, healthy subject group |
| Visually guided saccadesPatients as well as healthy control subjects will undergo testing of visually guided saccades in different conditions (step, gap, overlap) in order to compare latencies of covert saccades between both groups. | Other | Patients, healthy subject group |
Primary outcome
Latency of covert-saccades
Time frame: Day 1
Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade
4 secondary outcomes
Frequency of covert-saccades
Time frame: Day 1
Velocity of covert-saccades
Time frame: day 1
Amplitude of covert-saccades
Time frame: Day 1
Latency of visually-guided saccades
Time frame: Day 1
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 Sep 2025.
- Results publication: PubMed 40543046Lagadec V, Pelisson D, Koun E, Robert C, Froment Tilikete C, Hermann R. Oculomotor compensatory strategies in bilateral vestibulopathy: Predictive and active conditions of head movements. J Vestib Res. 2025 Nov;35(6):290-299. doi: 10.1177/09574271251355180. Epub 2025 Jun 21.
- Results publication: PubMed 39690450Hermann R, Ramat S, Colnaghi S, Lagadec V, Desoche C, Pelisson D, Froment Tilikete C. Catch-Up Saccades in Vestibulo-Ocular Reflex Deficit: Contribution of Visual Information? Ear Hear. 2025 May-Jun 01;46(3):719-728. doi: 10.1097/AUD.0000000000001616. Epub 2024 Dec 18.
- Results publication: PubMed 37064179Desoche C, Verdelet G, Salemme R, Farne A, Pelisson D, Froment C, Hermann R. Virtual reality set-up for studying vestibular function during head impulse test. Front Neurol. 2023 Mar 29;14:1151515. doi: 10.3389/fneur.2023.1151515. eCollection 2023.
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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.
Caroline FROMENT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covert Saccades and Virtual Reality, Actives versus passives Head Impulses and Visually guided saccades in people with Reflex, Abnormal and Bilateral Vestibulopathy, run by Hospices Civils de Lyon at 1 site in France.
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 15 inclusion and 10 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 Sep 2025. 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 France. 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?
Latency of covert-saccades (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268615, which also lists 3 linked publications.
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 Sep 2025.