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

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Civil Hospices of Lyon

Status

Completed

Conditions

Healthy Volunteers
Bilateral Vestibulopathy
Reflex, Abnormal

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04268615
69HCL19_0998
2020-A00184-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Patients
Experimental group
Description:
Patients suffering from chronic bilateral vestibular hypofunction
Treatment:
Other: Actives versus passives Head Impulses
Other: Visually guided saccades
Other: Covert Saccades and Virtual Reality
healthy subject group
Active Comparator group
Treatment:
Other: Actives versus passives Head Impulses
Other: Visually guided saccades
Other: Covert Saccades and Virtual Reality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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