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CompletedNCT02816632FeedbacksUpdated Sep 3, 2025

Feedbacks' Influence on Decision Making Processes

An interventional study of mRI and Effect of Galvanic Vestibular Stimulation on decision making processes in Healthy Volunteers, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

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

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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)

02

Conditions studied

  • Healthy Volunteers

Keywords

  • functional Magnetic Resonance Imaging
  • Galvanic Vestibular Stimulation
  • Feedback Processing
  • Reward, Social, Vestibular System
  • Cingulate Cortex
  • Decision-making
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 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Benefit of social health security
  • Normal or corrected-to-normal vision

Exclusion criteria

Exclusion Criteria:

  • 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
  • Alcohol assumption during the last 24 hours
  • Sleep deprivation
  • Recent participation to other brain stimulation studies (\< 1 week)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    healthy volunteers

    Other: mRI · Other: Effect of Galvanic Vestibular Stimulation on decision making processes

Interventions

  • OthermRI

    Neural bases of feedbacks' influence on decision making processes

  • OtherEffect of Galvanic Vestibular Stimulation on decision making processes

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 4 days

  2. 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).

    Time frame: 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).

    Time frame: up to 4 days

07

Study locations

1 site
  • Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
    Bron, 69500, France
08

References and documents

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 33130427 ↗
  • Blini 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02816632
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Mar 30, 2017
Primary completion
Sep 18, 2019
Completion
Sep 18, 2019
Last update
Sep 3, 2025

Study contacts

Caroline TILIKETE, MD
principal investigator · Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON

Oversight

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

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