Healthy VolunteersFeedbacksNCT02816632
Feedbacks' Influence on Decision Making Processes
A study testing mRI and Effect of Galvanic Vestibular Stimulation on decision making processes in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- mRI and Effect of Galvanic Vestibular Stimulation on decision making processes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2017to 18 Sep 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Benefit of social health security
- Normal or corrected-to-normal vision
Who cannot join
- Anamnesis of neurological of psychiatric illness
- Pregnancy or breastfeeding
- Administrative measures restricting legal rights
- Epilepsy (including familiarity), migraines, chronic headaches
- presence of pacemakers, cochlear implants, surgical clips, or any metallic component fixed in participants' body
- Current treatment with psychotropic drugs
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- Alcohol assumption during the last 24 hours
- Sleep deprivation
- Recent participation to other brain stimulation studies (< 1 week)
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
Bron, 69500
About this study
The purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised.
It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of feedback processing on decision making using different types of feedback (neutral, social and monetary) presented either infra- or supra-laminary and 2) probing the role of one structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy subjects. The interventional part consists in the administration of Galvanic Vestibular Stimulation (GVS), which by means of small intensity currents activates the vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to healthy participants engaged in behavioural tasks requiring the processing of feedbacks of different nature (e.g. social or monetary feedbacks)
- Conditions
- Healthy Volunteers
- Being tested
- mRI, Effect of Galvanic Vestibular Stimulation on decision making processes
- Keywords
- functional Magnetic Resonance Imaging, Galvanic Vestibular Stimulation, Feedback Processing, Reward, Social, Vestibular System, Cingulate Cortex, Decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRIOther
Neural bases of feedbacks' influence on decision making processes
Effect of Galvanic Vestibular Stimulation on decision making processesOther
Galvanic Vestibular Stimulation (GVS) stimulates the vestibular system through low intensity electric currents applied at the basis of the VIII cranial nerve, upon the mastoid processes. In the Right-Anodal condition the positive electric charge is applied through electrodes placed upon the right mastoid and it mainly activates structures within the left brain hemisphere. In the Left-Anodal condition the positive electric charge is applied through electrodes placed upon the left mastoid and it mainly activates structures within the right brain hemisphere. In the SHAM condition, low intensity electric currents are applied 5 cm below the mastoid processes. This condition does not activate the vestibular system and serves as a control condition to account for unspecific activating effects of all electric stimulations (e.g., arousal, discomfort). The three conditions will be applied in three different sessions (i.e. days) in randomized order.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Other: mRI; Other: Effect of Galvanic Vestibular Stimulation on decision making processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance (Accuracy)
The proportion of correct responses, automatically computed by professional programs (e.g. Presentation) running on standard Personal Computers depending on different contexts (e.g. different feedback: neutral, social and monetary).
Measured: up to 4 days
Behavioral performance (Reaction times)
The proportion of reaction times provided, automatically computed by professional programs (e.g. Presentation) running on standard Personal Computers depending on different contexts (e.g. different feedback: neutral, social and monetary).
Measured: up to 4 days
Secondary outcomes (1)
Neural activity (BOLD signal measured using fMRI) as a function of the nature of the feedback.
Neural activity changes during learning of visuomotor associations in different contexts (e.g. different feedback: neutral, social and monetary) measured using Blood-oxygen-level dependent contrast imaging (BOLD).
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start30 Mar 2017
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline TILIKETE, MD, Principal investigator, Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816632
- Sponsor's protocol ID
- 69HCL15_0221
- Other IDs
- 2015-A00623-46
- Acronym
- Feedbacks
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2016
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blini E, Tilikete C, Chelazzi L, Farne A, Hadj-Bouziane F. The role of the vestibular system in value attribution to positive and negative reinforcers. Cortex. 2020 Dec;133:215-235. doi: 10.1016/j.cortex.2020.09.004. Epub 2020 Oct 2.
PubMed 33130427Blini E, Tilikete C, Farne A, Hadj-Bouziane F. Probing the role of the vestibular system in motivation and reward-based attention. Cortex. 2018 Jun;103:82-99. doi: 10.1016/j.cortex.2018.02.009. Epub 2018 Feb 27.
PubMed 29574253
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedbacks' Influence on Decision Making Processes
- ClinicalTrials.gov ID
- NCT02816632
- Acronym / sponsor ID
- Feedbacks / 69HCL15_0221
- Conditions
- Healthy Volunteers
- Keywords
- functional Magnetic Resonance Imaging, Galvanic Vestibular Stimulation, Feedback Processing, Reward, Social, Vestibular System, Cingulate Cortex, Decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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 purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised.
It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of feedback processing on decision making using different types of feedback (neutral, social and monetary) presented either infra- or supra-laminary and 2) probing the role of one structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy subjects. The interventional part consists in the administration of Galvanic Vestibular Stimulation (GVS), which by means of small intensity currents activates the vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to healthy participants engaged in behavioural tasks requiring the processing of feedbacks of different nature (e.g. social or monetary feedbacks)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: mRI, Other: Effect of Galvanic Vestibular Stimulation on decision making processes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Benefit of social health security
- Normal or corrected-to-normal vision
Key exclusion criteria (9 listed)
- Anamnesis of neurological of psychiatric illness
- Pregnancy or breastfeeding
- Administrative measures restricting legal rights
- Epilepsy (including familiarity), migraines, chronic headaches
- presence of pacemakers, cochlear implants, surgical clips, or any metallic component fixed in participants' body
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 |
|---|---|---|
| mRINeural bases of feedbacks' influence on decision making processes | Other | healthy volunteers |
| Effect of Galvanic Vestibular Stimulation on decision making processesGalvanic Vestibular Stimulation (GVS) stimulates the vestibular system through low intensity electric currents applied at the basis of the VIII cranial nerve, upon the mastoid processes. In the Right-Anodal condition the positive electric charge is applied through electrodes placed upon the right mastoid and it mainly activates structures within the left brain hemisphere. In the Left-Anodal condition the positive electric charge is applied through electrodes placed upon the left mastoid and it mainly activates structures within the right brain hemisphere. In the SHAM condition, low intensity electric currents are applied 5 cm below the mastoid processes. This condition does not activate the vestibular system and serves as a control condition to account for unspecific activating effects of all electric stimulations (e.g., arousal, discomfort). The three conditions will be applied in three different sessions (i.e. days) in randomized order. | Other | healthy volunteers |
Primary outcome
Behavioral performance (Accuracy)
Time frame: up to 4 days
The proportion of correct responses, automatically computed by professional programs (e.g. Presentation) running on standard Personal Computers depending on different contexts (e.g. different feedback: neutral, social and monetary).
Behavioral performance (Reaction times)
Time frame: up to 4 days
The proportion of reaction times provided, automatically computed by professional programs (e.g. Presentation) running on standard Personal Computers depending on different contexts (e.g. different feedback: neutral, social and monetary).
1 secondary outcome
Neural activity (BOLD signal measured using fMRI) as a function of the nature of the feedback.
Time frame: up to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 33130427Blini E, Tilikete C, Chelazzi L, Farne A, Hadj-Bouziane F. The role of the vestibular system in value attribution to positive and negative reinforcers. Cortex. 2020 Dec;133:215-235. doi: 10.1016/j.cortex.2020.09.004. Epub 2020 Oct 2.
- Results publication: PubMed 29574253Blini E, Tilikete C, Farne A, Hadj-Bouziane F. Probing the role of the vestibular system in motivation and reward-based attention. Cortex. 2018 Jun;103:82-99. doi: 10.1016/j.cortex.2018.02.009. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No
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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.
Caroline TILIKETE, MD principal investigator
Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mRI and Effect of Galvanic Vestibular Stimulation on decision making processes in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral performance (Accuracy) (time frame: up to 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816632, which also lists 2 linked publications.
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 3 Sep 2025.