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Feedbacks' Influence on Decision Making Processes (Feedbacks)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816632
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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)


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: mRI Other: Effect of Galvanic Vestibular Stimulation on decision making processes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Feedbacks' Influence on Decision Making Processes
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 18, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: healthy volunteers Other: mRI
Neural bases of feedbacks' influence on decision making processes

Other: Effect 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816632


Locations
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France
Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Caroline TILIKETE, MD Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02816632    
Other Study ID Numbers: 69HCL15_0221
2015-A00623-46 ( Other Identifier: ID-RCB )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
functional Magnetic Resonance Imaging
Galvanic Vestibular Stimulation
Feedback Processing
 Reward, Social, Vestibular System
Cingulate Cortex
Decision-making