Boosting Reward-based Attention Through VEstibular STimulation (BRAVEST)

February 13, 2023 updated by: Hospices Civils de Lyon

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Procedure: Non-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.
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.
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.
Procedure: Non-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.
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.
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.
Procedure: Non-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Center of Gravity (pixels).
Time Frame: Days 1, 2, and 3
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.
Days 1, 2, and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaction times (ms).
Time Frame: Days 1, 2, and 3.
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
Days 1, 2, and 3.
Response accuracy (%)
Time Frame: Days 1, 2, and 3.
The proportion of correct responses provided, automatically computed by professional programs (e.g. Presentation) running on standard PCs.
Days 1, 2, and 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0263
  • 2017-A01784-49 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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