Feedbacks' Influence on Decision Making Processes (Feedbacks)

• ClinicalTrials.gov Identifier: NCT02816632
• Recruitment Status: Completed
• First Posted: June 28, 2016
• Last Update Posted: February 23, 2022
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: June 20, 2016
• First Posted Date: June 28, 2016
• Last Update Posted Date: February 23, 2022
• Actual Study Start Date: March 30, 2017
• Actual Primary Completion Date: September 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 24, 2016)

• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 24, 2016)

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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feedbacks' Influence on Decision Making Processes
• Official Title: Feedbacks' Influence on Decision Making Processes

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)

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Volunteers

Intervention

• 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.

Study Arms

Experimental: healthy volunteers

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2022): 76
• Original Estimated Enrollment (submitted: June 24, 2016): 90
• Actual Study Completion Date: September 18, 2019
• Actual Primary Completion Date: September 18, 2019 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02816632
• Other Study ID Numbers: 69HCL15_0221; 2015-A00623-46 ( Other Identifier: ID-RCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Caroline TILIKETE, MD; Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON

• PRS Account: Hospices Civils de Lyon
• Verification Date: February 2022