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Covert Saccade Triggers in Bilateral Vestibular Hypofunction (CS-TRIGGER)

Primary Purpose

Reflex, Abnormal, Bilateral Vestibulopathy, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Covert Saccades and Virtual Reality
Actives versus passives Head Impulses
Visually guided saccades
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Reflex, Abnormal focused on measuring Saccadic Eye Movements, Bilateral Vestibulopathy, Bilateral Vestibular Hypofunction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

  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:

  • 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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients

healthy subject group

Arm Description

Patients suffering from chronic bilateral vestibular hypofunction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2020
Last Updated
July 27, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04268615
Brief Title
Covert Saccade Triggers in Bilateral Vestibular Hypofunction
Acronym
CS-TRIGGER
Official Title
Covert Saccade Triggers in Bilateral Vestibular Hypofunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex, Abnormal, Bilateral Vestibulopathy, Healthy Volunteers
Keywords
Saccadic Eye Movements, Bilateral Vestibulopathy, Bilateral Vestibular Hypofunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients suffering from chronic bilateral vestibular hypofunction
Arm Title
healthy subject group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Covert Saccades and Virtual Reality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Actives versus passives Head Impulses
Intervention Description
Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.
Intervention Type
Other
Intervention Name(s)
Visually guided saccades
Intervention Description
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 Outcome Measure Information:
Title
Latency of covert-saccades
Description
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 Outcome Measure Information:
Title
Frequency of covert-saccades
Description
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
Title
Velocity of covert-saccades
Description
Velocity of covert saccades correspond to the maximal velocity of the first covert-saccade
Time Frame
day 1
Title
Amplitude of covert-saccades
Description
Amplitude of covert saccades correspond to amplitude of the first covert-saccade
Time Frame
Day 1
Title
Latency of visually-guided saccades
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline FROMENT, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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Covert Saccade Triggers in Bilateral Vestibular Hypofunction

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