- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816632
Feedbacks' Influence on Decision Making Processes (Feedbacks)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Benefit of social health security
- Normal or corrected-to-normal vision
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healthy volunteers
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Neural bases of feedbacks' influence 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
up to 4 days
|
|
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).
|
up to 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural activity (BOLD signal measured using fMRI) as a function of the nature of the feedback.
Time Frame: up to 4 days
|
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).
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up to 4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caroline TILIKETE, MD, Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL15_0221
- 2015-A00623-46 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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