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SuspendedNCT03213119BRAVESTUpdated Feb 15, 2023

Boosting Reward-based Attention Through VEstibular STimulation

An interventional study of Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. and Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. in Brain Lesion of the Right Hemisphere and Unilateral Spatial Neglect for Half of Them, sponsored by Hospices Civils de Lyon. Suspended at 2 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-15.

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

Why this study was suspended
number of planned study inclusions not achievable
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).

02

Conditions studied

  • Brain Lesion of the Right Hemisphere
  • Unilateral Spatial Neglect for Half of Them

Keywords

  • Caloric Vestibular Stimulation Reward
  • Brain Stimulation
  • Reward
  • Vestibular System
  • Cingulate Cortex
  • Cancellation Tasks
03

In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • More than 18 years of age, less than 85
  • right handed
  • Benefit of social health security
  • Normal or corrected-to-normal vision
  • Brain lesion localised in the right hemisphere, confirmed by CT or MRI

Exclusion criteria

Exclusion Criteria:

  • Anamnesis of neurological of psychiatric illness
  • Pregnancy or breastfeeding
  • Administrative measures restricting legal rights
  • Recent participation to other brain stimulation studies (\< 1 week)
  • Perforation of the tympanic membrane
  • Anamnesis of recurrent otitis media
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Caloric Vestibular Stimulation, Left-Warm

    Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Warm condition uses water with a temperature of 44°. It induces a nystagmus with its slow phase towards the right.

    Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

  • Experimental
    Caloric Vestibular Stimulation, Left-Cold

    Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Cold condition uses water with a temperature of 30°. It induces a nystagmus with its slow phase towards the left.

    Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

  • Sham comparator
    Caloric Vestibular Stimulation, SHAM

    The SHAM condition uses water with a temperature of 37°. It does not induce nystagmus

    Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Interventions

  • ProcedureNon-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

    Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

  • ProcedureNon-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

    Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

  • ProcedureNon-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

    Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function. The SHAM condition uses body-temperature water, and thus does not result into vestibular unbalance.

06

What researchers measure

Primary outcomes

  1. Center of Gravity (pixels).

    For line bisection defined as the difference between participants' mark and the objective center of the line. For cancellation tasks it is calculated as the grand average of horizontal and vertical coordinates of all the marks. In both cases smaller indices indicate a leftward exploration bias, whereas larger indices indicate rightward bias.

    Time frame: Days 1, 2, and 3

Secondary outcomes

  1. Reaction times (ms).

    The speed of response is a traditional indicator of the amount of cognitive processing underneath provided responses. It is measured by professional programs (e.g. Presentation) running on standard PCs

    Time frame: Days 1, 2, and 3.

  2. Response accuracy (%)

    The proportion of correct responses provided, automatically computed by professional programs (e.g. Presentation) running on standard PCs.

    Time frame: Days 1, 2, and 3.

07

Study locations

2 sites
  • CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)
    Bron, 69500, France
  • Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle
    Saint-Genis-Laval, 69230, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03213119
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 11, 2017
Start date
Apr 23, 2018
Primary completion
May 8, 2018
Completion
Feb 13, 2023 (estimated)
Last update
Feb 15, 2023

Oversight

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

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This study is suspended, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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