ClinicalTrials.gg
CompletedNCT04268615CS-TRIGGERUpdated Sep 2, 2025

Covert Saccade Triggers in Bilateral Vestibular Hypofunction

An interventional study of Covert Saccades and Virtual Reality and Actives versus passives Head Impulses in Reflex, Abnormal, Bilateral Vestibulopathy and Healthy Volunteers, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Reflex, Abnormal
  • Bilateral Vestibulopathy
  • Healthy Volunteers

Browse trials for

Keywords

  • Saccadic Eye Movements
  • Bilateral Vestibulopathy
  • Bilateral Vestibular Hypofunction
03

In context

Reflex, Abnormal

18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.

This study's enrollment of 32 is above the median of 16 across 13 interventional studies indexed under Reflex, Abnormal.

Browse Reflex, Abnormal studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • For all :

    • Age from 18 to 90
    • Understanding of the experimental instructions
  • 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

  1. Postural imbalance
  2. Unsteadiness of gait
  3. Movement-induced blurred vision or oscillopsia during walking or quick head/body movements
  4. 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).

D. Not better accounted for by another disease

* For Healthy control No ENT or neurological disorders

Exclusion criteria

Exclusion Criteria:

  • 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
  • Non-stabilized medical disease
  • Pregnant women
  • Patients under tutelage
  • Patient without social security
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Patients

    Patients suffering from chronic bilateral vestibular hypofunction

    Other: Covert Saccades and Virtual Reality · Other: Actives versus passives Head Impulses · Other: Visually guided saccades

  • Active comparator
    healthy subject group

    Other: Covert Saccades and Virtual Reality · Other: Actives versus passives Head Impulses · Other: Visually guided saccades

Interventions

  • OtherCovert Saccades and Virtual Reality

    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.

  • OtherActives versus passives Head Impulses

    Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.

  • OtherVisually guided saccades

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. Velocity of covert-saccades

    Velocity of covert saccades correspond to the maximal velocity of the first covert-saccade

    Time frame: day 1

  3. Amplitude of covert-saccades

    Amplitude of covert saccades correspond to amplitude of the first covert-saccade

    Time frame: Day 1

  4. 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

    Time frame: Day 1

07

Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69500, France
08

References and documents

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 40543046 ↗
  • Hermann 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 39690450 ↗
  • Desoche 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Mar 2022, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2020
First posted
Feb 13, 2020
StartActual
Dec 15, 2020
Primary completionActual
Mar 21, 2022
CompletionActual
Mar 21, 2022
Last update
Sep 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04268615
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Dec 15, 2020
Primary completion
Mar 21, 2022
Completion
Mar 21, 2022
Last update
Sep 2, 2025

Study contacts

Caroline FROMENT, MD
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion