NCT02816632

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

June 20, 2016

Last Update Submit

August 26, 2025

Conditions

Keywords

functional Magnetic Resonance ImagingGalvanic Vestibular StimulationFeedback ProcessingReward, Social, Vestibular SystemCingulate CortexDecision-making

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    up to 4 days

Secondary Outcomes (1)

  • Neural activity (BOLD signal measured using fMRI) as a function of the nature of the feedback.

    up to 4 days

Study Arms (1)

healthy volunteers

EXPERIMENTAL
Other: mRIOther: Effect of Galvanic Vestibular Stimulation on decision making processes

Interventions

mRIOTHER

Neural bases of feedbacks' influence on decision making processes

healthy volunteers

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.

healthy volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON

Bron, 69500, France

Location

Related Publications (2)

  • 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.

    PMID: 29574253BACKGROUND
  • 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.

    PMID: 33130427BACKGROUND

Study Officials

  • Caroline TILIKETE, MD

    Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 28, 2016

Study Start

March 30, 2017

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations