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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02816632
Other study ID # 69HCL15_0221
Secondary ID 2015-A00623-46
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2017
Est. completion date September 18, 2019

Study information

Verified date February 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 18, 2019
Est. primary completion date September 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
mRI
Neural bases of feedbacks' influence on decision making processes
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.

Locations

Country Name City State
France Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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). up to 4 days
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