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Completed

NCT Number: NCT04268615

Covert Saccade Triggers in Bilateral Vestibular Hypofunction

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.

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Key information

Conditions

Reflex, Abnormal Bilateral Vestibulopathy Ear Diseases Healthy Volunteers Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vestibular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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).

D. Not better accounted for by another disease

  • For Healthy control No ENT or neurological disorders

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

Treatment and study plan

Covert Saccades and Virtual Reality

Other

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 Impulses

Other

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 saccades

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Frequency of covert-saccades

    Time frame: Day 1

    Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.

  2. Velocity of covert-saccades

    Time frame: day 1

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

  3. Amplitude of covert-saccades

    Time frame: Day 1

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

  4. Latency of visually-guided saccades

    Time frame: Day 1

    Latency of visually guided saccades correspond to the time between the appearance of target and the initiation of the first saccade

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CS-TRIGGER

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 13, 2020
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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