Brain Lesion of the Right HemisphereBRAVESTNCT03213119
Boosting Reward-based Attention Through VEstibular STimulation
A study testing Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. in people with Brain Lesion of the Right Hemisphere and Unilateral Spatial Neglect for Half of Them, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Lesion of the Right Hemisphere, Unilateral Spatial Neglect for Half of Them
- What is being tested?
- Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Apr 2018to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)
Bron, 69500
Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
About this study
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).
- Being tested
- Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.
- Keywords
- Caloric Vestibular Stimulation Reward, Brain Stimulation, Reward, Vestibular System, Cingulate Cortex, Cancellation Tasks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.Procedure or surgery
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.
Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.Procedure or surgery
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.
Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Caloric Vestibular Stimulation, Left-Warm | Experimental | 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. Receives: Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. |
| Caloric Vestibular Stimulation, Left-Cold | Experimental | 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. Receives: Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. |
| Caloric Vestibular Stimulation, SHAM | Sham comparator | The SHAM condition uses water with a temperature of 37°. It does not induce nystagmus Receives: Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1, 2, and 3
Secondary outcomes (2)
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
Measured: Days 1, 2, and 3.
Response accuracy (%)
The proportion of correct responses provided, automatically computed by professional programs (e.g. Presentation) running on standard PCs.
Measured: Days 1, 2, and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start23 Apr 2018
- Primary completion8 May 2018
- Study completion13 Feb 2023 (estimated)
Why it stopped: number of planned study inclusions not achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Lesion of the Right HemisphereStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213119
- Sponsor's protocol ID
- 69HCL17_0263
- Other IDs
- 2017-A01784-49
- Acronym
- BRAVEST
- Status last verified
- Feb 2023
- First submitted
- 6 Jul 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Reward-based Attention Through VEstibular STimulation
- ClinicalTrials.gov ID
- NCT03213119
- Acronym / sponsor ID
- BRAVEST / 69HCL17_0263
- Keywords
- Caloric Vestibular Stimulation Reward, Brain Stimulation, Reward, Vestibular System, Cingulate Cortex, Cancellation Tasks
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: number of planned study inclusions not achievable
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 13 Feb 2023 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caloric Vestibular Stimulation, Left-Warm | Experimental | Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.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. |
| Caloric Vestibular Stimulation, Left-Cold | Experimental | Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.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. |
| Caloric Vestibular Stimulation, SHAM | Sham comparator | Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.The SHAM condition uses water with a temperature of 37°. It does not induce nystagmus |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Caloric Vestibular Stimulation, Left-Warm |
| 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 or surgery | Caloric Vestibular Stimulation, Left-Cold |
| 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. | Procedure or surgery | Caloric Vestibular Stimulation, SHAM |
Primary outcome
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.
2 secondary outcomes
Reaction times (ms).
Time frame: Days 1, 2, and 3.
Response accuracy (%)
Time frame: Days 1, 2, and 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation. in people with Brain Lesion of the Right Hemisphere and Unilateral Spatial Neglect for Half of Them, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Gravity (pixels). (time frame: Days 1, 2, and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.